ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A
ACRP CCRC Exam (Latest 2024/ 2025
Update) Questions and Verified Answers|
100% Correct| Grade A
Q: Which of the following is an unexpected adverse event?
a) A report which adds significant information to an already documented serious adverse event
b) A report of interstitial nephritis in a patient with acute renal failure
c) A report of fulminant hepatitis in patient with an initial report of hepatitis d) All of the above
Answer:
d) All of the above
Q: For expedited reporting an event must be a) Serious
b) Serious and unexpected
c) Only temporally associated with drug administration
d) Causally related to drug administration
Answer:
b) Serious and unexpected
Q: According to ICH serious unexpected reaction to a drug should be a) Submitted to the
appropriate regulatory authority within one week b) Submitted to the appropriate regulatory
authority within 15 days
c) Submitted to the appropriate regulatory authority on an expedited basis d) Submitted promptly
to the IRB
Answer:
c) Submitted to the appropriate regulatory authority on an expedited basis
Q: Clinical investigation of adverse events in clinical trials requires a) Root cause analysis
b) Complete medical records review
c) Investigation of potential protocol deviations d) Causality assessment
Answer:
a) Root cause analysis
Q: Adverse events of marketed drugs usually imply a) Multi-drug interactions
b) Unreliable subjective measures c) Psychosomatic factors
d) Causality
Answer:
d) Causality
Q: Rapid communication of single case reports of serious adverse events is merited if the
information
a) Influences risk benefit assessment
b) Implies a change need in drug administration
c) A change in the conduct of the clinical investigation d) All of the above
Answer:
d) All of the above
Q: Expedited reporting of serious adverse events may be considered if a) There is an increased
rate of occurrence in the serious adverse drug reaction
b) A lack of efficacy is evident in treating a life-threatening disease c) A new safety consideration
is evident from a new animal study d) All of the above
Answer:
d) All of the above
Q: Fatal or life threatening and unexpected adverse drug reactions in clinical investigations
should be reported to the regulatory agencies (check all that apply)
a) No later than 7 days after first knowledge of event
b) No later than 15 days after first knowledge of event
c) By filing a complete report within 8 additional days of the initial notification d) By filing a
complete report within 15 additional days of the initial notifica- tion
Answer:
a) No later than 7 days after first knowledge of event
c) By filing a complete report within 8 additional days of the initial notification
Q: Serious adverse drug reactions must be filed with regulatory agencies a) As soon as possible,
but not later than 8 days of first knowledge
b) As soon as possible, but not later than 10 days of first knowledge c) As soon as possible, but
not later than 15 days of first knowledge
d) As soon as possible, but not later than 1 month of first knowledge
Answer:
c) As soon as possible, but not later than 15 days of first knowledge
Q: In ascertaining the basis for a serious adverse drug reaction in a random- ized trial
a) Care should be taken not to break the blind for the patient
b) Care should be taken to break the blind only for the single patient involved c) The blind for
the group of patients being treated at the site should be broken d) The blind for the single patient
should be broken only if the sponsor approves
Answer:
b) Care should be taken to break the blind only for the single patient involved
Q: Breaking the blind for a single patient in randomized clinical trial a) Has negative
implications for data integrity at the site level
b) Has little or no significant implication for the investigation or final data analysis
c) May compromise drug approval because of implications for final data analysis
d) Provides no significant information regarding the safety of the patient
Answer:
b) Has little or no significant implication for the investigation or final data analysis
Q: Adverse drug reactions in the control group should be reported to a) The other manufacturer
b) Appropriate regulatory agency c) a only
d) a and b
Answer:
d) a and b
Q: An adverse reaction occurs in patients after the study has been completed. The appropriate
action on the part of the investigator include
a) Report the event to the sponsor
b) Consider the event for reporting as though it was a study report
c) Conduct causality assessment and determination of expectedness prior to expedited reporting
d) All of the above
Answer:
d) All of the above
Q: New safety information regarding a study drug should be updated by the sponsor by
a) Notifying the IRB
b) Notifying the investigator c) Updating the protocol
d) Updating the Investigator’s Brochure
Answer:
d) Updating the Investigator’s Brochure
Q: An unexpected adverse drug reaction is a reaction a) Happens immediately after drug
administration
b) Is inconsistent with the documented product information in the investiga- tor’s brochure or
other source document
c) Known to occur frequently in preclinical studies
d) Dependent on the dose the drug
Answer:
b) Is inconsistent with the documented product information in the investigator’s brochure or
other source document
Q: An adverse event that is severe in intensity a) May qualify for expedited reporting
b) Could be classified as a serious adverse event
c) May not meet the definition of a serious adverse event
d) Need not be reported to the sponsor if it is part of the disease condition
Answer:
c) May not meet the definition of a serious adverse event
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c) Is not necessarily causally related to drug An adverse event is defined as one whicha) Results in hospitalizationb) Causes a disabilityc) Is not necessarily causally related to drugd) Is life threatening
adverse event Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
An adverse event is one whicha) Is an unfavorable and unintended sign, symptom or diseaseb) Is one that is temporally associated with drug regardless of whether it is related or notc) a onlyd) a and b d) a and b a) Is an unfavorable and unintended sign, symptom or disease
a) An adverse event
b and c b)A causal relationship between drug and adverse event is a reasonable possibility
responses to a medicinal products This phrase means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.
b) A noxious and unintended response to a drug An adverse drug reaction is one whicha) Results in death or hospitalizationb) A noxious and unintended response to a drugc) Occurs frequently and with greater severity than usuald) Likely occurs at normal doses of the drug
adverse drug reaction response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function
For a drug that is in a Phase IV trial and adverse drug reaction is one whicha) Is noxious and unintendedb) Occurs at normal doses used for prophylaxisc) a onlyd) a and b d) a and b a) Is noxious and unintended
Phase IV What phase study looks at drugs that have already been approved by the FDA. The drugs are available for doctors to prescribe for patients, but this study might still be needed to answer important questions. These studies may involve thousands of people.
A serious adverse event is on which results ina) Death or life threatening eventb) A hospitalization or prolongation of hospitalizationc) Persistent or significant disabilityd) Congenital anomaly or birth defect e) All of the above e) All of the above a) Death or life threatening event
“b) An event where risk of death was evident at the time of the eventAn adverse event or suspected adverse reaction is considered “”life-threatening”” if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death. … Serious adverse event or serious suspected adverse reaction.” The term, life threatening, in a serious adverse event refers toa) An event which required hospitalizationb) An event where risk of death was evident at the time of the eventc) An event that required treatment in an emergency roomd) An event which might have caused a death if left untreated
An event may be classified as serious if ita) Not immediately life threatening, but may jeopardize the patientb) Not immediately life threatening but may require and intervention to prevent hospitalizationc) a onlyd) a and b d) a and b a) Not immediately life threatening, but may jeopardize the patient
d) May be considered serious and should be considered for expedited reporting A patient in a clinical I trial for joint pain experiences a bronchospasm while at home, The event would bea) Not reportable because it occurred in a home settingb) An adverse event which does not require reportingc) An unexpected adverse event which does not require expedited reportingd) May be considered serious and should be considered for expedited reporting
Events which may be classified as serious even though they do not result in hospitalization includea) Allergic bronchospasm b) Blood dyscrasias c) Convulsionsd) All of the above d) All of the above a) Allergic bronchospasm
b) Not mentioned in the investigator’s brochure or relevant source document An unexpected adverse reaction is one which isa) Not expected by the investigatorb) Not mentioned in the investigator’s brochure or relevant source documentc) Classified as such by the IRBd) Classified as such by the sponsor’s medical safety officer
Which of the following is an unexpected adverse eventa) A report which adds significant information to an already documented serious adverse eventb) A report of interstitial nephritis in a patient with acute renal failurec) A report of fulminant hepatitis in patient with an initial report of hepatitisd) All of the above d) All of the above a) A report which adds significant information to an already documented serious adverse event
b) Serious and unexpected For expedited reporting and event must be a) Serious b) Serious and unexpected c) Only temporally associated with drug administration d) Causally related to drug administration
c) Submitted to the appropriate regulatory authority on an expedited basis According to ICH serious unexpected reaction to a drug should bea) Submitted to the appropriate regulatory authority within one weekb) Submitted to the appropriate regulatory authority within 15 daysc) Submitted to the appropriate regulatory authority on an expedited basisd) Submitted promptly to the IRB
d) Causality assessment
d) Causality Adverse events of marketed drugs usually implya) Multi-drug interactionsb) Unreliable subjective measuresc) Psychosomatic factorsd) Causality
Rapid communication of single case reports of serious adverse events is merited if the informationa) Influences risk benefit assessmentb) Implies a change need in drug administrationc) A change in the conduct of the clinical investigationd) All of the above d) All of the above a) Influences risk benefit assessment
Expedited reporting of serious adverse events may be considered ifa) There is an increased rate of occurrence in the serious adverse drug reactionb) A lack of efficacy is evident in treating a life-threatening diseasec) A new safety consideration is evident from a new animal studyd) All of the above d) All of the above a) There is an increased rate of occurrence in the serious adverse drug reaction
a and c a) of event
but not later than 15 days of first knowledge c) As soon as possible,
b) Care should be taken to break the blind only for the single patient involved In ascertaining the basis for a serious adverse drug reaction in a randomized triala) Care should be taken not to break the blind for the patientb) Care should be taken to break the blind only for the single patient involvedc) The blind for the group of patients being treated at the site should be brokend) The blind for the single patient should be broken only if the sponsor approves
b) Has little or no significant implication for the investigation or final data analysis Breaking the blind for a single patient in randomized clinical triala) Has negative implications for data integrity at the site levelb) Has little or no significant implication for the investigation or final data analysisc) May compromise drug approval because of implications for final data analysisd) Provides no significant information regarding the safety of the patient
Adverse drug reactions in the control group should be reported toa) The other manufacturerb) Appropriate regulatory agencyc) a onlyd) a and b d) a and b a) The other manufacturer
An adverse reaction occurs in patients after the study has been completed. The appropriate action on the part of the investigator includea) Report the event to the sponsorb) Consider the event for reporting as though it was a study reportc) Conduct causality assessment and determination of expectedness prior to expedited reportingd) All of the above d) All of the above a) Report the event to the sponsor
d) Updating the Investigator’s Brochure New safety information regarding a study drug should be updated by the sponsor bya) Notifying the IRBb) Notifying the investigatorc) Updating the protocold) Updating the Investigator’s Brochure
b) Is inconsistent with the documented product information in the investigator’s brochure or other source document An unexpected adverse drug reaction is a reactiona) Happens immediately after drug administrationb) Is inconsistent with the documented product information in the investigator’s brochure or other source documentc) Known to occur frequently in preclinical studiesd) Dependent on the dose the drug
c) May not meet the definition of a serious adverse event An adverse event that is severe in intensitya) May qualify for expedited reportingb) Could be classified as a serious adverse eventc) May not meet the definition of a serious adverse eventd) Need not be reported to the sponsor if it is part of the disease condition
d) That merely describes the intensity of the medical event To be characterized as severe an adverse event is onea) That qualifies for expedited reportingb) Is always life threateningc) Is always one that can be characterized as seriousd) That merely describes the intensity of the medical event
d) None of the above Which of the following statements is correct?a) An adverse event is one that is always viewed as potentially seriousb) An adverse event is an adverse drug reactionc) An adverse event qualifies for expedited reporting d) None of the above
c) Has a reasonable suspected causal relationship to the drug
c) A serious adverse drug reaction d) Cannot be characterized as serious as it is reflective of the disease and not the drug
d)All of the above a) An autopsy report
a) Declaration of Helsinki The ethical principles underlying clinical study management are stated ina) Declaration of Helsinkib) Belmont reportc) Nuremberg Coded) CIOMS guidelines
c) Studies in animal models The term non-clinical studies refers toa) Studies in vitro cell culture modelsb) Studies in organ culturec) Studies in animal modelsd) Pilot human studies
c) Should be sufficient to indicate safety in human studies Nonclinical studiesa) Should be performed in at least three speciesb) Must include a disease animal modelc) Should be sufficient to indicate safety in human studiesd) Are not needed before some human studies
Toxicology studies in animal modelsa) Should be reviewed by qualified expertsb) Assessed for their implications of subject safetyc) a onlyd) a and b d) a and b a) Should be reviewed by qualified experts
c) Sound scientific design Clinical trial protocols should reflecta) Reasonable costs for the clinical trialb) Minimize sample sizes to reduce risksc) Sound scientific designd) The use of control groups whenever possible.
The responsibility for the protection of clinical trial subjects rests witha) IRB/IECb) Investigatorc) Sponsord) All of the above d) All of the above a) IRB/IEC
a) Phase I
b) Phase II
c) Phase III
d) Phase IV
a) Human Pharmacology
d) Continue throughout the development plan Characterization of drug’s absorption, metabolism and excretiona) Are confined to Phase I studiesb) Cab be conducted in Phase II studies if Phase I studies are inconclusivec) Are never studied in Phase Ill studiesd) Continue throughout the development plan
d) b only b) Phase II studies
b) Phase II pharmacological endpoints or clinical measures
c) Phase III
d) Phase IV
d) Phase IV pharmacoeconomic
Considerations for determining the nature and timing of non-clinical studies includea) Duration and total exposure prosed in individual patientsb) Long half lifec) Route of administrationd) All of the above d) All of the above a) Duration and total exposure prosed in individual patients
For first in human studies the administered dose should be determined bya) Pharmacokineticsb) Drug pharmacologyc) Toxicological evaluationsd) All of the above d) All of the above a) Pharmacokinetics
d) Comparative bioavailability studies
b) Bioavailability Formulations of the drug should be characterized ona) Maximum tolerated doseb) BioavailabilityC) Half -lifed) Drug clearance
b) Elderly
Study objectives in clinical trial design may includea) Safety and efficacy characterizationb) Pharmacokinetic and pharmacological studiesc) Physiological and biochemical studiesd) All of the above d) All of the above a) Safety and efficacy characterization
a) Cost assessment of proposed clinical trial
Which of the following statements is truea) Trial subjects should not enroll in more than one trial at any given timeb) Women of childbearing potential should use highly effective contraception measuresc) Male subjects should be made aware of hazard of drug exposure to their sexual partners or progenyd) All of the above d) All of the above a) Trial subjects should not enroll in more than one trial at any given time
a) A group of a distinct age composition
a) Clinical trial logistics and cost controls
b) Exclude safety considerations
d) Qualitative
Methods to minimize bias includea) Randomizationb) Blindingc) Compliance measuresd) All of the above d) All of the above a) Randomization
a) A section for assessment of conflict of interest
d) Approved use by the regulatory agency Phase IV protocols generally followa) Phase I protocolsb) Phase II protocolsc) Phase III protocolsd) Approved use by the regulatory agency
a) Study endpoints Response variables are closely related toa) Study endpointsb) Primary objectivesc) Secondary Objectivesd) Statistical Plan
b) Subjects with cancer Phase 1 studies of a cancer drug are done ina) Healthy volunteersb) Subjects with cancerc) Subjects with cancer who have failed conventional therapyd) Subjects with cancer with more than a year’s anticipated survival
d) Included in the study protocol Methods to be used in assessing patient drug use and compliance are besta) Discussed verbally with the subjectb) Need not be mentioned in the informed consentc) Need not be discussed with subjectsd) Included in the study protocol
b) Should be planned with children in mind from the very outset Planning of clinical trials with childrena) Should await the results of a trials in adultsb) Should be planned with children in mind from the very outsetc) Should exclude children agesd) Should be planned predominantly in adolescents
a) Efficacy The primary concern in a confirmatory trial isa) Efficacyb) Safetyc) Pharmacodynamicsd) Pharmacokinetics
Statistical principles are relevant toa) Phase I trialsb) Phase II trialsc) Phase III trialsd) All of the above d) All of the above a) Phase I trials
c) Deviation in the estimation of a treatment effect from its true value Bias is defined asa) Error in miscalculation of the final drug effectb) Trend to extrapolation in missing valuesc) Deviation in the estimation of a treatment effect from its true valued) Failure to use a complete data set for analysis
Factors associated with bias can includea) Study designb) Study conductc) Data analysis and interpretationd) All of the above d) All of the above a) Study design
d) The health status of the subjects in the clinical trial
A development plan purpose is toa) Find a dose range that is simultaneously safe and effectiveb) Prove that the risk benefit relationship is acceptablec) Identify the subjects who would most benefit and indications for the used) All of the above d) All of the above a) Find a dose range that is simultaneously safe and effective
b) Test the key hypothesis, effect size and clinical significance In a confirmatory trial the following applya) Phase 1 results are verified in phase 2 trialsb) Test the key hypothesis, effect size and clinical significancec) Conduct the trial in a large sample of subjectsd) The design is that described for the use of an approved drug
a and c a) Explore a wide range of hypotheses
c) Is always significantly large in Phase 1 trials to ensure reliable toxicology results
c) Must provide significant support for secondary variables
Secondary variables musta) Be supportive measurements related to the primary objectiveb) Need to have their role and importance defined carefully in a clinical trialc) Should be limited to answering a limited number of questions in the trial.d) All of the above. d) All of the above. a) Be supportive measurements related to the primary objective
d) Are never used as a primary variable in most clinical trials
d) Often allow for an assessment of benefits relative to adverse effects.
For a surrogate variable to be reliable, they shoulda) Have a plausible relationship to clinical outcomeb) Be supported by epidemiologic evidencec) Reflect a treatment effect that corresponds to clinical outcomed) All of the above d) All of the above a) Have a plausible relationship to clinical outcome
A double blind trial is one in which the following are unaware of the treatment receiveda) Sponsorb) Investigatorc) Subjectd) All of the above d) All of the above a) Sponsor
In a double blind trial the person who should be unaware of the treatment should not be involved in assessinga) Eligibilityb) Endpointsc) Complianced) All of the above d) All of the above a) Eligibility
a) Subject In a single blind trial the person who is unaware of the treatment isa) Subjectb) Investigatorc) Monitord) Clinical coordinator
a) Subject and investigator In an open label trial the persons who should be aware that the treatment is being administered area) Subject and investigatorb) Pharmacist and investigatorc) Sponsor and investigatord) Monitor and investigator
c) Should be implemented when deemed essential for subject’s care Breaking the blind for a single subjecta) Implies breaking the blind for the study groupb) May be done at the discretion of the monitorc) Should be implemented when deemed essential for subject’s cared) Always involves a serious adverse event
a) Randomized to two arms each with a different treatment In a parallel group design the subjectsa) Randomized to two arms each with a different treatmentb) Are evaluated before and after drug administrationc) Are randomized to a sequence of two treatmentsd) Are evaluated simultaneously for varying combinations of treatments
c) Are randomized to a sequence of two treatments In a crossover design the subjectsa) Randomized to two arms each with a different treatmentb) Are evaluated before and after drug administrationc) Are randomized to a sequence of two treatmentsd) Are evaluated simultaneously for varying combinations of treatments
b) Are evaluated before and after drug administration In a pre-post design the subjectsa) Randomized to two arms each with a different treatmentb) Are evaluated before and after drug administrationc) Are randomized to a sequence of two treatmentsd) Are evaluated simultaneously for varying combinations of treatments
d) Are evaluated simultaneously for varying combinations of treatments In a factorial design the subjectsa) Randomized to two arms each with a different treatmentb) Are evaluated before and after drug administrationc) Are randomized to a sequence of two treatmentsd) Are evaluated simultaneously for varying combinations of treatments
a) Parallel design The most commonly used study design in clinical trials isa) Parallel designb) Crossover designc) Pre-Post designd) Factorial design
For a successful crossover designa) Carryover from a pervious treatment should be minimizedb) The disease should be chronic and stablec) Drug effects should develop fully within the treatment periodd) All of the above d) All of the above a) Carryover from a pervious treatment should be minimized
d) Are easily administered for uniform implementation of the protocol
Drug efficacy is best established bya) Demonstrating superiority to placebo in a placebo control trialb) Demonstrating superiority in an active control trialc) Demonstrating a dose -response relationshipd) All of the above d) All of the above a) Demonstrating superiority to placebo in a placebo control trial
a) The drug has been shown to be efficacious in a superiority trial A placebo controlled trial would be considered unethical ifa) The drug has been shown to be efficacious in a superiority trialb) The drug has been shown equivalent to active control in a non-inferiority trialc) Drug has shown serious side effects in preclinical studiesd) All of the above
An equivalence or non-inferiority trial is one in whicha) Efficacy of a test drug is no worse than an active comparatorb) Multiple doses of a test drug are compared to multiple doses of as standard drugc) a onlyd) a and b d) a and b a) Efficacy of a test drug is no worse than an active comparator
c) A drug that has shown efficacy in a superiority trial An active control is best represented bya) Any drug that has shown activity against the diseaseb) A drug that has been shown to be non-inferior in an equivalence trialc) A drug that has shown efficacy in a superiority triald) All of the above
c) The projected cost of the trial for the designated sample size
a) Type I error The probability of erroneously rejecting the null hypothesis is described asa) Type I errorb) Type II errorc) Type Ill errord) Risk assessment
b. Type II error The probability of erroneously failing to reject the null hypothesis is described asa. Type I errorb. Type II errorc. Type Ill errord. Risk assessment
Data collection in a clinical trial usually employsa) Paper case record formsb) Remote site monitoringc) Medical computer systems and electronic transferd) All of the above d) All of the above a) Paper case record forms
The type of monitoring in a confirmatory clinical trial may includea) Oversight of the quality of the clinical trialb) Breaking the blind for treatment comparison and interim analysisc) a onlyd) a and b d) a and b a) Oversight of the quality of the clinical trial
b) Conflict of interest
c) Should remain constant during a clinical trial Inclusion and exclusion criteriaa) Can be set to maximize enrollmentb) Are independent of preclinical studiesc) Should remain constant during a clinical triald) May change as needed during a clinical trial
The ideal data analysis set is one in whicha) Procedures are followed perfectlyb) Data records are completec) There is no loss to patient follow upd) All of the above d) All of the above a) Procedures are followed perfectly
Irregularities in the data analysis set may arise froma) Protocol violationsb) Patient withdrawalsc) Missing valuesd) All of the above d) All of the above a) Protocol violations
d) All randomized subjects The intention to treat analysis set includesa) All treated subjectsb) Only subjects with complete drug treatmentsc) Subjects who have undergone the minimum number of acceptable trial visitsd) All randomized subjects
c) Evaluable subjects compliant with the protocol The Per protocol analysis data set includesa) All randomized subjectsb) All subjects who have not undergone SAEsc) Evaluable subjects compliant with the protocold) Subjects with no missed visits as specified in the schedule of assessments
Criteria used for inclusion of data in the per protocol data set includea) Completion of minimal exposure to treatmentb) Available measure of the primary variablesc) Absence of protocol violations and eligibility criteriad) All of the above d) All of the above a) Completion of minimal exposure to treatment
a) Full analysis set only In confirmatory trials, it is usual to analyzea) Full analysis set onlyb) Per protocol Set onlyc) Full analysis and per protocol setsd) Null hypothesis analysis set
c) Contribute to bias Missing values in a data seta) Are generally discounted in data analysisb) Are eliminated by extrapolationc) Contribute to biasd) Have no effect on hypothesis testing
Covariates in a statistical analysis may includea) Variation in populations between centers in a multi-center trailb) Variations in age subgroupsc) Variations by genderd) All of the above d) All of the above a) Variation in populations between centers in a multi-center trail
Pre analysis review should include considerations ofa) Exclusion of subjects from the data setb) Transformation of the variablesc) Impact an statistical treatment of outliersd) All of the above d) All of the above a) Exclusion of subjects from the data set
c) Continuously during drug development Safety and tolerability of the drug are best assessed ina) Phase I trialsb) Phase 11 trialsc) Continuously during drug developmentd) Phase Ill trials
d) Between trial completion and breaking of the blind Blind review occursa) At various stages of a clinical trialb) After study close out visit for all sites has been completedc) At pre-specified intervalsd) Between trial completion and breaking of the blind
c) Technique to retain the blind when administering supplies to non-identical groups The term double dummy refers toa) Double blinded trialb) Placebo controlled trialc) Technique to retain the blind when administering supplies to non-identical groupsd) All of the above
a) The safety data The DSMB monitorsa) The safety datab) Patient accrualc) Data accuracyd) Missing data
a) Continuation, modification or termination of a sponsor’s trial The DSMB can recommend a) Continuation, modification or termination of a sponsor’s trialb) The continued enrollment of patients in light of safety eventsc) The submission of serious adverse safety events for regulatory reviewd) The submission of serious adverse safety events to the IRB.
c) Single or double blind Methods to avoid the bias in a clinical trial generally involvea) Single-blind onlyb) Double-blind onlyc) Single or double blindd) Open label
b) Confirmatory trial A trial designed on the basis of some evidence of benefits is likely to bea) Exploratory trialb) Confirmatory trialc) Phase IV triald) Open label trial
d) Any stage of clinical drug development Mutlicenter trials can be implemented fora) Open label trialsb) Exploratory trialsc) Confirmatory trialsd) Any stage of clinical drug development
d) Results of phase I trials in adults
d) Pilot studies in a small relevant group of children.
Formulation of pediatric drugs may require the need fora) Chewable tablets and liquid formulationsb) Safe and easily injectable formulationsc) Frequent use of suspensionsd) All of the above. d) All of the above. a) Chewable tablets and liquid formulations
c) Type of disease and safety and efficacy of alternate treatments The timing of pediatric studies of a drug is dependent ona) Completion of Phase 1 trials in adultsb) Successful non clinical studiesc) Type of disease and safety and efficacy of alternate treatmentsd) Known safety profile of the drug in the adult population
Development of drug for a disease exclusively affecting the pediatric population requiresa) The entire development program in children onlyb) Safety and tolerability data obtained in adultsc) a onlyd) a and b c) a only a) The entire development program in children only
b) Studies in pediatric populations with the disease Pharmacokinetic studies of a pediatric drug requiresa) Studies in adults with the diseaseb) Studies in pediatric populations with the diseasec) Studies in healthy childrend) Studies preferably carried out in older children or adolescents
d) Mg/kg body weight Dosing recommendations for pediatric drugs are based ona) Body areab) Renal clearancec) Liver metabolismd) Mg/kg body weight
noxious harmful, poisonous, or very unpleasant
Congenital anomalies
serious adverse event (SAE) in human drug trials it is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage
Bronchospasm or a bronchial spasm is a sudden constriction of the muscles in the walls of the bronchioles. It is caused by the release of substances from mast cells or basophils under the influence of anaphylatoxins. It causes difficulty in breathing which ranges from mild to severe
Phase I Study • Assess tolerance, Define/describe PK1and PD2, Explore drug metabolism and drug interactions, Estimate activity
allergic bronchospasm often affects people with asthma and allergies. It contributes to asthma symptoms like wheezing and shortness of breath; your chest also feels tight, and it can be hard to catch your breath
Blood dyscrasias A nonspecific term for a defect in the blood
Unexpected adverse event or suspected adverse reaction refers to an event or reaction that is not listed in the investigator’s brochure or is not listed at the specificity or severity that has been observed; or, if an investigator’s brochure is not required or available, is not consistent with the risk information
no later than 15 calendar days after first knowledge by the sponsor
Root cause analysis (RCA) In science and engineering, it is a method of problem solving used for identifying the root causes of faults or problems. It is widely used in IT operations, telecommunications, industrial process control, accident analysis (e.g., in aviation, rail transport, or nuclear plants), medicine (for medical diagnosis), healthcare industry (e.g., for epidemiology), etc.
Causality assessment
no case later than 7 calendar days after the sponsor’s initial receipt of the information.
ascertaining find (something) out for certain; make sure of
Investigator’s Brochure (IB) “In drug development, what is a comprehensive document summarizing the body of information about an investigational product (“”IP”” or “”study drug””) obtained during a drug trial. It is a document of critical importance throughout the drug development process and is updated with new information as it becomes available.”
Adverse event (AE) Any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment.
adverse drug reaction (ADR) drug drugs
Severe adverse drug reactions abnormal heart rhythms certain types of allergic reactions
The Declaration of Helsinki a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
The Belmont Report A report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Nuremberg Code is a set of research ethics principles for human experimentation created as a result of the Nuremberg trials at the end of the Second World War
“The CIOMS guidelines is an abbreviation for the “”Council for International Organizations of Medical Sciences”””
Non-Clinical Studies
toxicology vitro
Phase III Study • Explore use for the targeted indication, Estimate dosage for subsequent studies, Provide basis for confirmatory study design, endpoints, methodologies • Earliest trials of relatively short duration in well- defined narrow patient populations, using surrogate or pharmacological endpoints or clinical measures, Dose-response exploration studies
Phase III Study • Demonstrate/confirm efficacy, Establish safety profile, Provide an adequate basis for assessing the benefit/risk relationship to support licensing, Establish dose-response relationship • Adequate, and well controlled studies to establish efficacy, Randomised parallel dose response studies, Clinical safety studies, Studies of mortality/ morbidity outcomes, Large simple trials, Comparative studies
Phase IV Study Monitor long-term effects
Epidemiological studies studies that measure the risk of illness or death in an exposed population compared to that risk in an identical, unexposed population (for example, a population the same age, sex, race and social status as the exposed population)
Pharmacoeconomics the science of measuring costs and outcomes associated with the use of pharmaceuticals in health-care delivery. Its objective is to improve public health through rational decision making when selecting among alternative therapies, e.g., for formularies and their impact on costs and outcomes
Clinical pharmacokinetic
Bioavailability Is a measure of how easily and quickly nutrients can be absorbed and used by the body after consumption. Simply consuming particular nutrients or taking healthy supplements does not guarantee that they will safely make their way through your intestinal tract, to your bloodstream, and ultimately to your cells.
Qualitative means relating to, measuring, or measured by the quality of something rather than its quantity
interim analysis
response variable
confirmatory clinical trial
robust or robustness
exploratory trial
secondary variable A term used in clinical trials for the outcome variable specified in the study protocol that is of greatest importance to the trial’s primary objective, and usually the one used in the sample size calculation.
single variable In a clinical trial, it is usually in the form of a scale of ordered categorical ratings—that integrates objective variables and the investigator’s overall impression about the state or change in state of a subject as a result of the trial’s intervention or therapy.
surrogate variable
double-blind study “an experimental procedure in which neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment; “”a procedure is used to guard against both experimenter bias and placebo effects”””
Single-Blind Study a single-blind study is a type of experiment or clinical trial in which the experimenters are aware of which subjects are receiving the treatment or independent variable, but the participants of the study are not
open-label trial, or open trial
parallel group design
Crossover design
pretest-posttest design A design is an experiment in which measurements are taken on individuals both before and after they’re involved in some treatment. Pretest-posttest designs can be used in both experimental and quasi-experimental research and may or may not include control groups.
factorial design is one of the many experimental designs used in psychological experiments where two or more independent variables are simultaneously manipulated to observe their effects on the dependent variables
multicenter research trial is a clinical trial conducted at more than one medical center or clinic
Efficacy Is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as effectiveness, and it has often been used synonymously, although in pharmacology a distinction is now often made between that word and effectiveness.
placebo-controlled trial In a trial that one group of participants (the control arm) receives an inactive drug (or other intervention), called a placebo, while another group of participants (the experimental arm) receives the active drug being tested. The two groups are compared to see if the drug is more effective than the placebo.
non-inferiority or equivalence trials Trials which compare treatments may not be designed to show that one treatment is superior. These trials aim to show that the new drug is no worse than standard treatment.
“Active control”” (or “”Active Comparator””)” “means that a known, effective treatment (as opposed to a placebo) is compared to an experimental treatment. In other words, every person in an active control clinical trial is given a treatment that works (or potentially works), instead of some receiving an inactive “”sugar pill”””
null hypothesis In inferential statistics, it is a default hypothesis that a quantity to be measured is zero
Type I Error “Is a statistical term that is also known as a “”false positive””: the error of rejecting a null. Hypothesis when it is actually true. In other words, this is the error of accepting an. alternative hypothesis (the real hypothesis of interest) when the results can be. attributed to chance.”
Type II Error Is a statistical term used within the context of hypothesis testing that describes the error that occurs when one accepts a null hypothesis that is actually false, because we accept the conclusion of the test as negative, even though it is incorrect.
Double dummy Is a technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo).A double blind study is a randomized clinical trial in which: You as the patient don’t know if you’re receiving the experimental treatment, a standard treatment or a placebo
data monitoring committee – sometimes called a data and safety monitoring board (DSMB) an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing
Pilot studies Preliminary studies that are small-scaled which aim to investigate whether crucial components of a main study – usually a randomized controlled trial (RCT) – will be feasible. The reporting of these studies must be of high quality to allow readers to interpret the results and implications correctly.
pharmacokinetic study A standard study that is the conventional method for evaluating the the movement of drugs within the body of a drug in human subjects. In such a study, subjects are given a single dose or repeated doses of an investigational drug. Then, blood and urine samples are collected in compliance with a fixed schedule.
pharmacokinetics the branch of pharmacology concerned with the movement of drugs within the body
b) Based on guidelines in DHHS regulations The institutional review board in the United States sets the blood volume that can be obtained from a childa) Based on institutional policyb) Based on guidelines in DHHS regulationsc) Based on disease severityd) Based on the age of the child.
IRB (Institutional Review Board) An institutional review board, also known as an independent ethics committee, ethical review board, or research ethics board, is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical.Under FDA regulations, that is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, this group has the authority to approve, require modifications in (to secure approval), or disapprove research.
DDHS Regulations (the Department of Health and Human Services) The Code of Federal Regulations at 45 CFR 46 describes the regulation requirements for the protection of human subjects. This regulation require that research involving human participants be subject to oversight by an IRB to ensure that the rights and welfare of research participants are protected.
b) No more than twice weekly The typical restriction on blood draws form children in the United States is set ata) No more than once weeklyb) No more than twice weeklyc) No more than three time weeklyd) No more than four times weekly
a) No more than 50 ml in an eight week period The amount of blood volume that may be obtained form a child in the United States is set ata) No more than 50 ml in an eight week periodb) No more than a 100 ml in one monthc) No more than 20 ml in one weekd) No more than one unit in four weeks
The amount of blood obtained from a child in a clinical trial may be minimized by the following methodsa) Use of sensitive assays and indwelling catheters for sampling and analyzing drugs and metabolitesb) Use of laboratories specialized in handling small blood volumesc) Collection of research samples at the same time as clinical care samplesd) All of the above d) All of the above a) Use of sensitive assays and indwelling catheters for sampling and analyzing drugs and metabolites
d) Are particularly important as the pediatric database is limited at the time of approval Phase IV studies in pediatric populationsa) Are not required as there is no regulation that outlines the needb) Are rarely done because safety information is already documented in Phase III trialsc) Are recommended only if Phase IV studies in the adult population have not been doned) Are particularly important as the pediatric database is limited at the time of approval
Age classifications of pediatric subjects in ICH includesa) Preterm newborn infantsb) Term newborn infantsc) Infants and toddlersd) All of the above d) All of the above a) Preterm newborn infants
c) Varies by state in the United States The definition of a child as classified by age in the United Statesa) Is specified in the Federal regulationsb) Is designated as being the same in countries that are signatories to ICH guidelinesc) Varies by state in the United Statesd) Is set at 18 years as a universal standard
b) Between 12 to 16-18 years of age ICH defines an adolescent as a person who isa) Between 14 and 18 years of ageb) Between 12 to 16-18 years of agec) Between 13 and 17 years of aged) Between 16 to 18 years of age
International Conference on Harmonization (ICH) What document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.
Features pertinent to drug metabolism in a Preterm new born includea) Immaturity of renal and hepatic clearance mechanismb) Drug binding and displacement from proteinsc) Penetration into the CNSd) Unique neonatal conditionse) Rapid maturation of physiologic processes that radically influence drug dosingf) Transdermal absorption of drugsg) All of the above g) All of the above a) Immaturity of renal and hepatic clearance mechanism
d) Immaturity of the blood brain barrier may give rise to CNS toxicity In term new born infants features of drug metabolism includea) Stable renal and hepatic clearance compared to preterm newbornsb) Oral administration of the drug is predictable and preferredc) Dose adjustments are unlikely to be needed in the course of a clinical triald) Immaturity of the blood brain barrier may give rise to CNS toxicity
d) Clearance of drugs on a mg/kg basis may exceed adult values In infants and toddlers features of drug metabolism includea) Hepatic and renal clearance are stableb) Oral absorption is as unreliable as in newbornsc) The CNS maturation is nearly completed) Clearance of drugs on a mg/kg basis may exceed adult values
Drug metabolism
In children 2-11 years of age factors to consider in clinical trials includea) Tanner staging for pubertyb) Recreational use of drugs, alcohol and tobaccoc) a onlyd) Both a and b d) Both a and b a) Tanner staging for puberty
The Tanner scale (also known as the Tanner stages)
d) Interpersonal interactions with other children
c) Should have a member or experts consulted who are knowledgeable in pediatric ethics and psychosocial issues IRBs reviewing pediatric clinical trialsa) Are required to have a pediatrician according to the regulationsb) May review the studies without a pediatricianc) Should have a member or experts consulted who are knowledgeable in pediatric ethics and psychosocial issuesd) Should have pediatrician who is trained in the disease subspecialty of the clinical trial.
c) The compensation should be divided between the parent and the child
inducement a thing that persuades or influences someone to do something
subsistence the action or fact of maintaining or supporting oneself at a minimum level
b) The pediatric subject is usually legally incapable of providing informed consent In pediatric clinical trialsa) The assent of the child always overrides the permission of the parentb) The pediatric subject is usually legally incapable of providing informed consentc) The approval of both parents is requiredd) A witness to the consent process is mandatory
assent the expression of approval or agreement
In pediatric clinical trialsa) Participants should sign assent or consent depending on their intellectual maturityb) Participants should always be made aware of their right to declinec) a onlyd) Both a and b d) Both a and b a) Participants should sign assent or consent depending on their intellectual maturity
b) May be overridden by the investigator or parent for serious or life threatening diseases Withdrawal of pediatric subject from a clinical traila) Is always permittedb) May be overridden by the investigator or parent for serious or life threatening diseasesc) Depends on the regulations of the countryd) Requires the consent of both parents
a) Minimize the number of study subjects
c) Assessment of the level of risk In the United States pediatric clinical research studies are designated different categories based ona) Disease severityb) Complexity of study designc) Assessment of the level of riskd) Age range of the study participants
b) Use of age appropriate gifts as compensation
c) Use of anesthesia in MRI procedures
Procedures to minimize the amount of blood sampled in pediatric clinical trials include a) Population PK samplingb) Sparse samplingc) In dwelling cathetersd) All of the above d) All of the above a) Population PK sampling
a) They are required to assess the effects on development Phase IV studies in the pediatric population differ from those in adult populations becausea) They are required to assess the effects on developmentb) They are less likely to yield safety information because of age variationc) The large samples required for such studies are hard to find in pediatric populationsd) Unlike adult populations regulations do not require Phase IV pediatric studies
d) Children In designing a study in which participants have mature hepatic and renal function you would choosea) Neonatesb) Preterm infantsc) Participants between the ages of 1-2 yearsd) Children
d) 2-11 years In ICH children are defined as between the ages ofa) 7-13yearsb) 2-6 yearsc) 4-11 yearsd) 2-11 years
d) Noncompliance A major problem in studies with adolescents isa) Drug addictionb) Peer pressurec) Conflicting school and personal schedulesd) Noncompliance
examination a) A systematic and independent of trial related activities and documents
Official review c) of documents, facilities, records and any other resources
d) Overseeing of the progress of a clinical trial
b) An investigation intended to discover and verify the clinical effects of an investigational product
conduct a) A person responsible for the of the clinical trial
initiation, management c) A person/entity responsible for and of a clinical trial.
overseeing the progress d) A person responsible for of a clinical trial
supervised by the team leader b) An individual
when needed c) A person responsible for assuming, , the responsibilities of an investigator/team leader
a) Planned and systematic action to ensure that the data is generated ,recorded and reported according to GCP
d) Not assume responsibility during an audit for the confidentiality of the clinical trial records.
e) Site monitoring reports
c) Audits are generally performed by a regulatory authority whereas monitoring is done by a CRO or sponsor
a) Declaration of Helsinki
d) The importance of the objective may in certain circumstances outweigh the risk to the subject
c) The protocol should reflect sound design is affirmed in both ICH and DHHS Which of the following regarding the protocol for a clinical trial is correcta) The protocol should reflect sound design is affirmed in DHHS but not ICHb) The protocol should reflect sound design is reflected in ICH but not DHHSc) The protocol should reflect sound design is affirmed in both ICH and DHHSd) There is no reference to sound design in either DHHS or ICH.
b) ICH and DHHS The role specifically of medical physician as responsible for medical decisions is affirmed ina) DHHS onlyb) ICH and DHHSc) ICH onlyd) OHRP
c) ICH, FWA and NIH guidelines The requirement that each individual involved in conducting a clinical trial should be qualified by education and training is affirmed ina) ICH onlyb) ICH and the FWA onlyc) ICH, FWA and NIH guidelinesd) Not explicitly stated in the regulations
Federalwide Assurance (FWA)
The National Institutes of Health (NIH)
c) Informed consent should be obtained from every subject Regarding informed consent in clinical trials ICH states thata) Waivers of informed consent are possibleb) Waiver of documentation of informed consent may be givenc) Informed consent should be obtained from every subjectd) Parental permission should be given only when it is a reasonable protection
d) Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements Regarding the protection of privacy and confidentiality, ICH:a) States that specific guidelines be followed for the protection of confidentialityb) Affirms the principles of HIPAA in privacy and confidentialityc) Does not mention privacy and confidentiality explicitly in its guidelinesd) Affirms that privacy and confidentiality be protected in accordance with applicable regulatory requirements
d) Affirms that handling and storage be in accordance with GMP. Regarding the storage and handling of investigational products ICHa) Assigns the responsibility to the principal investigator onlyb) Assigns responsibility to the CRO and study monitorc) Does not mention storage and handlingd) Affirms that handling and storage be in accordance with GMP.
Good Manufacturing Practice (GCP) defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines
d) The IRB should review the quality control measures of a clinical trial.
a) Should be in writing as part of the protocol or in a separate agreement Agreements between the sponsor and the investigator:a) Should be in writing as part of the protocol or in a separate agreementb) May be verbally implementedc) Must be provided to the IRB prior to study approvald) May be signed by the CRO on behalf of the sponsor
d) Is similar to DHHS in its requirements
a) Protocol, consent, recruitment procedures, investigator’s brochure, payments According to ICH the IRB should obtain the following documents from the investigatora) Protocol, consent, recruitment procedures, investigator’s brochure, paymentsb) Protocol , consent, case report forms , payments, CVc) Protocol, consent, monitoring plan, payments, CV, recruitmentd) Protocol, monitoring plan, investigator’s brochure, payments, CV
d) Current According to ICH the copy of the CV given to the IRB should bea) No more than a year oldb) No more than two years oldc) No date on the CV is requiredd) Current
CV a brief account of a person’s education, qualifications, and previous occupations, typically sent with a job application
d) DHHS, ICH, and FDA The statement that continuing review be carried out at least once annually is affirmed bya) ICH onlyb) DHHS and ICH onlyc) DHHS onlyd) DHHS, ICH, and FDA
d) Requirements for review of non-therapeutic trials. The IRB requirements in ICH differ from DHHS requirements ina) Requiring annual continuing reviewb) Ability for approval or disapprovalc) Ability for termination or suspensiond) Requirements for review of non-therapeutic trials.
Non-therapeutic trials Trials are ones which do not provide a treatment to patients, but instead study important factors which help advance the understanding of cancer and its impact. For example, of those studies collect tissue specimens to examine the cellular structure of a cancer tumor.
d) ICH states that if consent of subject or LAR cannot be obtained then relevant ethical concerns and applicable regulatory requirements be addressed. Regarding ICH provisions for emergency use of an investigational article which of the following is applicable?a) ICH describes guidelines for emergency use similar to those required by the FDA.b) ICH makes a provision for emergency medical care similar to that provided in DHHSc) ICH describes guidelines for use of an investigational article in an emergency settingd) ICH states that if consent of subject or LAR cannot be obtained then relevant ethical concerns and applicable regulatory requirements be addressed.
With regard to payments to subjects ICH indicates thata) Payments be free of coercion and undue influenceb) Payments should be proratedc) Methods, amounts and schedule of payments be set forth in the informed consent.d) All of the above. d) All of the above. a) Payments be free of coercion and undue influence
c) DHHS and FDA The guidelines for IRB composition in ICH are the same as those ina) DHHS onlyb) FDA onlyc) DHHS and FDAd) CIOMS
The Council for International Organizations of Medical Sciences (CIOMS) represents a substantial proportion of the biomedical scientific community through its member organizations, which include many of the biomedical disciplines, national academies of sciences and medical research councils
a) The IRB should comply with GCP An important affirmation regarding the ICH guidelines for the IRB which differ from DHHS regulation is thata) The IRB should comply with GCPb) Should have at least five membersc) Should have a non-scientific memberd) Should have a non-affiliated member
d) It should be stipulated in the written procedures
stipulate demand or specify (a requirement), typically as part of a bargain or agreement
d) Conflict of interest is defined as financial interest greater than $10000.
c) DHHS and ICH That the investigator may make changes in a protocol without IRB approval to eliminate an immediate hazard is stated ina) DHHS onlyb) ICH onlyc) DHHS and ICHd) Not stated exactly in either DHHS or ICH.
According to ICH the investigator should promptly report the following to the IRB:a) Deviations from protocol to eliminate immediate hazardsb) Changes in risk in protocolc) Serious and unexpected adverse drug reactionsd) New information that may affect the safety of subjectse) All of the above e) All of the above a) Deviations from protocol to eliminate immediate hazards
d) Written procedures and membership lists According to ICH, the sponsor may request the following from the IRBa) A copy of the minutes of an IRB meetingb) IRB correspondence with OHRPc) Rationale for IRB disapprovald) Written procedures and membership lists
According to ICH the investigator shoulda) Demonstrate the potential for recruiting the required number of subjectsb) Have sufficient time and staff to conduct the trialc) Ensure that the delegated staff be informed about the protocol, duties and productd) All of the above d) All of the above a) Demonstrate the potential for recruiting the required number of subjects
According to ICH the investigator shoulda) Ascertain the reason for withdrawal of a subjectb) Inform a subject’s physician about subject participation in a clinical trialc) Ensure that adequate care is provided for any adverse event experienced by the subjectd) All of the above d) All of the above a) Ascertain the reason for withdrawal of a subject
b) It is the investigator’s responsibility With regard to keeping the IRB informed about the Investigator’s brochure ICH states thata) It is the sponsor’s responsibilityb) It is the investigator’s responsibilityc) It is not neededd) Updates to the brochure need not be provided.
If the investigator implements a change in the protocol to eliminate an immediate hazard the following entities should be informed:a) The IRBb) The sponsorc) Regulatory authority if applicabled) All of the above d) All of the above a) The IRB
d) The pharmacist ICH recommends that responsibility for the investigational product and its accountability be assigned toa) The sub-investigatorb) The research coordinatorc) The study monitord) The pharmacist
d) All of the abovea) Delivery and inventory at the trial siteb) Use and return of the productc) Batch ,serial numbers and expiration dates Drug accountability for the investigational product includesa) Delivery and inventory at the trial siteb) Use and return of the productc) Batch ,serial numbers and expiration dates d) All of the above
With regard to randomization the investigator should:a) Follow the sponsor’s randomization planb) Explain to the sponsor any premature unblinding due to an adverse eventc) Both a and bd) Neither a nor b c) Both a and b a) Follow the sponsor’s randomization plan
c) Signed and dated by the subject and the person obtaining consent According to ICH the informed consent should bea) Signed but not dated by the subjectb) Signed and dated by the subject onlyc) Signed and dated by the subject and the person obtaining consentd) Witnessed for all consent situations
e) The number of subjects in the trial. e) The number of subjects in the trial.
The ICH guidelines differ from DHHS guidelines in that theya) Describe in detail the features of a non-therapeutic trialb) Describe the process of managing non-therapeutic trialsc) Affirm the need for signed and dated consent and IRB approval of non-therapeutic trialsd) All of the above d) All of the above a) Describe in detail the features of a non-therapeutic trial
1.1 The following agreements between sponsor and investigator should be documented in writinga) Financial arrangements and contractsb) Protocol agreement documentc) Investigator’s brochure receipt and confidentiality documentd) All of the above d) All of the above a) Financial arrangements and contracts
According to ICH the case report forms should bea) Consistent with source documentsb) Dated, initialed and explained when neededc) Show the original when corrections are maded) All of the above d) All of the above a) Consistent with source documents
a) Immediately Serious adverse events in a clinical trial should be reported to the sponsor according to ICHa) Immediatelyb) Within one dayc) Within one weekd) As time permits
When the IRB suspends a clinical trial it should informa) The institutionb) The sponsorc) OHRPd) All of the above d) All of the above a) The institution
d) The sponsor According to ICH the ultimate responsibility for the quality and integrity of the data rests witha) The investigatorb) The research coordinatorc) The site monitor and CROd) The sponsor
Contract Research Organization (CRO) an organization hired by a company in the medical field to manage the company’s clinical trials and perform other tasks to help bring a drug or device to the market
d) Part 11 compliance Under ICH the sponsor’s responsibilities for electronic data handling includes all of the following excepta) Accuracy, reliability and consistent performance guided by SOPsb) Security and backup of the system and access to authorized individuals onlyc) Safeguarding of the blindingd) Part 11 compliance
it is compliance that dictates that those companies who use electronic systems for document and signature control must provide assurance that the electronic documents are authentic. The regulations all stipulate the necessity of the confidentiality of electronic records. What is 21 CFR Part 11 compliance?
b) Two years If the sponsor discontinues clinical development of a drug the records of a clinical trial should be retained fora) One yearb) Two yearsc) Three yearsd) Four years
In ICH, with regard to the retention of records by the investigator, the sponsora) Can request retention for as long as the sponsor needs the datab) Can request retention for at least two years post NOA approval, according to FDA guidelinesc) Should notify the investigator in writing when the records are no longer neededd) All of the above d) All of the above a) Can request retention for as long as the sponsor needs the data
According to ICH the purpose of monitoring isa) Protect the rights and well-being of human subjectsb) Ensure data are accurate complete and verifiablec) The conduct of the trial is in agreement with the protocol, GCP and regulatory requirementsd) All of the above d) All of the above a) Protect the rights and well-being of human subjects
With regard to the training of monitors ICH states that they should bea) Appropriately trained with documented qualificationsb) Have the needed scientific and clinical knowledgec) Familiar with the protocol and the consent formd) All of the above d) All of the above a) Appropriately trained with documented qualifications
a) Objective, design, complexity, blinding and size In determining the extent of monitoring the sponsor should considera) Objective, design, complexity, blinding and sizeb) Objective, payments, complexity, blinding, costc) Objective, drug supply, payments, complexity, costd) Objective, site support, payments, complexity, blinding
d) Serve as the main line of communication between the sponsor and the investigator. The monitor shoulda) Serve as the person who decides on whether a trial should continue at the siteb) List complaints about Pl behaviorc) Train the research coordinator in their daily dutiesd) Serve as the main line of communication between the sponsor and the investigator.
a) Verify that the investigator has adequate qualifications, resources, facilities and staff With regard to the investigator the monitor shoulda) Verify that the investigator has adequate qualifications, resources, facilities and staffb) Verify whether the investigator meets regularly with staffc) Verify whether the investigator is delivering on all 1572 commitmentsd) Check on the Pl’s characteristics by talking to staff.
With regard to drug accountability the monitor shoulda) Verify storage items and adequacy of suppliesb) Verify whether eligible patients are getting the drug at the right dosesc) Verify whether subjects are informed and trained about drug use and storaged) Verify the receipt, use, return and disposition of unused druge) All of the above e) All of the above a) Verify storage items and adequacy of supplies
a) Routine site visits The study monitor reviews case report forms duringa) Routine site visitsb) Site initiation visitc) Study close out visitd) Pre-study visit
c) Study close out visit
b) Site initiation visit The study monitor reviews the protocol and schedule of assessments with the staff duringa) Routine site visitsb) Site initiation visitc) Study close out visitd) Pre-study visit
d) Pre-study visit The study monitor assesses the investigator’s qualification, resources and facilities duringa) Routine site visitsb) Site initiation visitc) Study close out visitd) Pre-study visit
h) The budget for the site and accuracy of financial disclosures e) Recruitment rate f) Case report forms and source documents
a) Periodic site monitoring reports The site monitor’s findings should be summarized ina) Periodic site monitoring reportsb) E-mails to the investigatorc) Verbal communication with research coordinatorsd) Summarized at the close out visit
According to ICH when non-compliance which is serious or persistent is observed the sponsor shoulda) Terminate the investigator’s participation in the clinical trialb) Inform the IRBc) Inform the regulatory authoritiesd) All of the above d) All of the above a) Terminate the investigator’s participation in the clinical trial
a) Carefully define the responsibilities of the coordinating site principal investigator According to ICH in multi-center trials the sponsor shoulda) Carefully define the responsibilities of the coordinating site principal investigatorb) Delegate monitoring to the coordinating sitec) Allow different standards of compliance depending on the sited) Permit changes in the CRFs for sites that may suggest these
Regarding protocol and GCP deviations observed by the monitor in a periodic site visit the sponsor maya) Require that these be reported promptly to the IRBb) Institute a corrective measure promptlyc) Develop a CAPA plan as neededd) All of the above d) All of the above a) Require that these be reported promptly to the IRB
b) They be recorded and explained on the appropriate CRFs Regarding withdrawals or drop outs among study subjects, ICH recommends thata) They be reported to the IRB.b) They be recorded and explained on the appropriate CRFsc) Notifications be sent to the regulatory authoritiesd) Notification be sent to the institution.
case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research, is the tool used by the sponsor of the clinical trial to collect data from each participating patient
f) IRB communication guidelines f) IRB communication guidelines
g) Conflict of interest disclosure e) Statistical analysis f) Publication policy
e) All screened subjects
e) All of the above a) Sample size and power calculations
b) ICH Description of the investigator’s brochure is included ina) DHHS regulationsb) ICHc) FDA regulations and guidanced) OHRP regulations and guidance
Investigator’s Brochure (IB) “In drug development, this comprehensive document summarizing the body of information about an investigational product (“”IP”” or “”study drug””) obtained during a drug trial. This document is a document of critical importance throughout the drug development process and is updated with new information as it becomes available.”
According to ICH the investigator’s brochure should includea) Physical, chemical and pharmaceutical properties and formulationsb) Nonclinical studies including nonclinical pharmacologyc) Pharmacokinetics and toxicologyd) Effects in humanse) Summary of data and guidance for the investigatorf) All of the above f) All of the above a) Physical, chemical and pharmaceutical properties and formulations
The investigator brochure is a living document that is continually updated in a clinical trial to includea) The latest nonclinical studiesb) Changes in chemistry of the productc) The latest results from completed clinical trialsd) All of the above d) All of the above a) The latest nonclinical studies
j) Forms 1571 and 1572 e) Financial aspects and insurance information f) IRB approvals
e) All of the above a) Enrollment and screening logs
d) All of the above a) Final close out study monitoring report
According to ICH the following statements about the involvement of a CRO in a clinical trial are correct:a) A sponsor may transfer any or all of the trial related duties and functions to a CROb)The CRO should implement quality assurance and quality controlc)The delegated CRO responsibilities should be specified in writingd) AII of the above d) AII of the above a) A sponsor may transfer any or all of the trial related duties and functions to a CRO
g) Preparation of the investigator’s brochure and the updates d) Monitoring data integrity and quality e) Reviewing the delegation of authority log
f) Protocol preparation and DSMB management d) Implementing and monitoring payments to subjects. e) Collection of SAE reports and forwarding to sponsor
Data and Safety Monitoring Board (DSMB) An independent group of experts that advises NIDCR. The members of this group serve in an individual capacity and provide their expertise and recommendations.
(NIDCR) National Institute of Dental and Craniofacial Research Scientific Director
The Medical Safety Officer at the sponsor carries out which of the duties listed below?a) Providing medical advice during the clinical trialb) Assessing medical waivers of eligibilityc) Review of SAEs and continuance of subjects on the studyd) All of the above. d) All of the above. a) Providing medical advice during the clinical trial
Which of the duties listed below are typically carried out by the sponsor and not the CRO?a) Protocol preparation and updatesb) Investigator brochure preparation and updatesc) Correspondence and interaction with the FDAd) Manufacture and supply of investigational druge) Preparation of the pharmacy manualf) Management of the DSMBg) All of the above g) All of the above a) Protocol preparation and updates
If the investigator terminates a trial at the site without prior approval from the sponsor he should inform the following in writing of this decisiona) IRBb) Institutionc) Sponsord) All of the above d) All of the above a) IRB
Regarding the issuance of a final report by the investigator the ICH advises that the investigator shoulda) Inform the institutionb) Provide the IRB with a summary of the trial’s outcomec) Provide regulatory authorities with any reports that may be required, if applicable.d) All of the above d) All of the above a) Inform the institution
According to ICH, for an investigator to be eligible to conduct a clinical trial he should bea) Qualified by education, training and experienceb) Meet the qualification specified by regulatory authorities and the IRBc) Should provide documentary evidence of his qualifications to the sponsor and the IRBd) All of the above d) All of the above a) Qualified by education, training and experience
d) Financial analysts
c) Provide insurance or indemnify the investigator ICH advises that in terms of compensation for claims arising during a clinical trial the sponsor shoulda) Not provide any assurances to the siteb) Assume negligence on the part of the Plc) Provide insurance or indemnify the investigatord) Compensate only life threatening emergencies on the part of the subject.
idemnify compensate (someone) for harm or loss; reimbursesecure (someone) against legal responsibility for their actions; insure
d) Punitive actions to be taken against the Pl or study coordinator
punitive inflicting or intended as punishment; disciplinary, corrective(of a tax or other charge) extremely high.
d) Send the audit report to the IRB. Regarding the sponsor’s audits of a clinical trial ICH advises all of the following excepta) Written procedures to be followed in the event of an auditb) The audit plan takes into account the complexity and importance of the clinical trialc) Where applicable an audit certificate should be issuedd) Send the audit report to the IRB.
d) A noxious and unintended response to a drug at any dose An adverse drug reaction isa) A congenital birth defect caused by a drugb) An event described in the Adverse Drug Reaction Tabulation at the FDAc) A repeat hospitalization caused by progression of diseased) A noxious and unintended response to a drug at any dose
c) A causal relationship between a drug and an adverse event that is possible A response to a medical product in the context of an adverse drug reaction is best defined asa) An event documented in the medical recordb) A deathc) A causal relationship between a drug and an adverse event that is possibled) An event that occurs in the time frame of drug administration
d) An event in which the relationship cannot be ruled out A possible relationship of an adverse drug reaction to a drug may be defined as onea) Reported by the patientb) Suspected by the Principal investigatorc) An event that is discontinued when the drug is discontinuedd) An event in which the relationship cannot be ruled out
d) A medical occurrence which may not be causally related to a drug An adverse event is defined asa) A mild clinical event not associated with hospitalizationb) An episode that interrupts a daily activityc) An event that requires a doctor’s visitd) A medical occurrence which may not be causally related to a drug
b) All adverse drug reaction may be classified as adverse events Which of the following is true?a) All adverse events are adverse drug reactionsb) All adverse drug reaction may be classified as adverse eventsc) An adverse event is never classified as an adverse drug reactiond) An adverse drug reaction excludes mild adverse events
d) An event temporally associated with drug use which may or may not be drug related. An adverse event is one which occursa) Within ten days of drug administrationb) An event which may occur after study treatments have been completedc) An event which occurs immediately after drug administrationd) An event temporally associated with drug use which may or may not be drug related.
Steps to reduce bias in clinical trial includea) Blindingb) Maskingc) Randomizationd) All of the above d) All of the above a) Blinding
Double blind study design entails that the following are unaware of the treatment assignmenta) Subjectb) Investigatorc) Monitord) All of the above d) All of the above a) Subject
a) The subject In a single blind trial the person unaware of the treatment assignment isa) The subjectb) The investigatorc) The monitord) The data analyst
d) Reduce bias on the part of subject and investigator The purpose of a double blind design is to ensurea) Deceive the subjectb) Reduce the bias on the part of the investigatorc) Reduce the bias on the part of the subjectd) Reduce bias on the part of subject and investigator
The types of bias on the part of the investigator that are reduced or eliminated by blinding may includea) Making Changes in the protocol eligibility criteria that may favor the sponsorb) Data falsification and fabricationc) Lack of Reporting of protocol deviations and serious adverse eventsd) All of the above d) All of the above a) Making Changes in the protocol eligibility criteria that may favor the sponsor
c) Altered behavior which may subvert the objective of the trial The bias on part of a subject in a clinical trial would best be represented bya) Complaints to OHRP regarding the IRBb) Noncompliance with the visitation schedulec) Altered behavior which may subvert the objective of the triald) Non-authorized variation in the drug dosing schedule.
d) Contract Research Organization The term CRO stands fora) Certified Research Organizationb) Certified Research Officerc) Contract Research Officiald) Contract Research Organization
f) Represents a mandatory regulatory guidance for clinical trial management e) Assurance that the rights, integrity and confidentiality of trial subjects is protected f) Represents a mandatory regulatory guidance for clinical trial management
a) Supports SAE review by the IRB
d) Is usually integrated into the monitoring schedule. An inspection of a clinical trial is all of the following excepta) Usually performed by a regulatory authorityb) Consists of a review of documents, facilities, records and any other resources at the sitec) May occur at the site or at the sponsor or CRO locationd) Is usually integrated into the monitoring schedule.
An institution (medical) is defined as a site for clinical trials and includesa) Any public or private entity or agencyb) A medical facilityc) A dental facilityd) All of the above d) All of the above a) Any public or private entity or agency
d) Is usually certified by the institution An impartial witness is all of the following excepta) A person who cannot be unfairly influencedb) Attends the informed consent conference when the subject or LAR cannot readc) Reads any written information supplied to the subjectd) Is usually certified by the institution
A monitor ensures that a clinical trial is being performed as specified ina) The protocolb) Standard operating proceduresc) Good Clinical Practice and other regulatory requirementsd) All of the above d) All of the above a) The protocol
d) May apply to human studies with high risk and no benefit A non clinical study is one which is all of the following excepta) Includes all animal studiesb) Any non human studyc) Usually precedes human studiesd) May apply to human studies with high risk and no benefit
d) Is authorized to make financial decisions on behalf of the trial subject if hospitalized.
d) Is often decided by a coin toss
e) Pregnant womenf) Fetuses and neonatesj) The elderlyI) Uneducated or illiterate individuals e) Pregnant women f) Fetuses and neonates
d) Subjects enrolled in more than one clinical trial at the same time
b) Sponsor Responsibility for the investigational product rests with thea) Monitorb) Sponsorc) CROd) Investigator
Regarding the use of the investigational product the investigator shoulda) Maintain records that the subjects were provided with the doses stated in the protocolb) Ensure that the drug was used only as described in the protocolc) Should ensure that the drug use is explained to the subject and compliance is verifiedd) All of the above d) All of the above a) Maintain records that the subjects were provided with the doses stated in the protocol
d) An impartial witness should be present If the subject or the LAR is unable to read the informed consenta) The subject should not be considered for enrollmentb) Written permission should be obtained from the IRB prior to enrollmentc) A family member should be recruited to explain the consentd) An impartial witness should be present
c) Ensure that the information was understood and consent freely given by the subject The primary role of the witness is to ensure thata) Provide emotional support to the subjectb) Satisfy the IRB that the informed consent process is adequatec) Ensure that the information was understood and consent freely given by the subjectd) Verify that signatures and dates on the consent are adequate.
The essential documents for a clinical trial should be retained fora) At least two years after discontinuation of clinical development of the drugb) For a period of longer than two years if applicable regulatory requirements demand itc) As long as the sponsor deems it necessaryd) All of the above d) All of the above a) At least two years after discontinuation of clinical development of the drug
Premature termination of a clinical trial should be reported by the investigator toa) The research subjectsb) The regulatory authority if applicablec) The IRBd) All of the above d) All of the above a) The research subjects
If the IRB suspends a clinical trial the investigator should report it toa) The sponsorb) The institutionc) The regulatory authorityd) Both a and b d) Both a and b a) The sponsor
The final report of the investigator should be provided toa) The IRBb) The regulatory authorityc) Both a and bd) The institution c) Both a and b a) The IRB
d) Trial subjects where appropriate Individuals utilized by the sponsor for all stages of the clinical trial process may include all of the following excepta) Biostatisticiansb) Clinical pharmacologistsc) Physiciansd) Trial subjects where appropriate
a) The EDC vendor is approved by the IRB With regard to electronic trial data the sponsor should ensure all of the following excepta) The EDC vendor is approved by the IRBb) The data changes are documentedc) There is no deletion of entered datad) An audit, data and edit trials are maintained .
c) Use an identification code For identification of all subject data the sponsor shoulda) Use the medical record numberb) Use the namec) Use an identification coded) Use a social security number or driver’s license number
d) The investigator/institution with protocol and the investigator’s brochure Before entering an agreement with the investigator/institution the sponsnor should providea) The IRB with the protocolb) The investigator/institution with the protocol onlyc) The investigator/institution with investigator’s brochured) The investigator/institution with protocol and the investigator’s brochure
c) Defined established and allocated by the sponsor Delegation of authority to the staff at the site level should bea) Done independently by the investigatorb) Approved by the IRBc) Defined established and allocated by the sponsord) Delegated to the CRO
With regard to liability claims that may arise against the investigator/institution the sponsor shoulda) Provide indemnificationb) Provide insurance where possiblec) Specify compensation for trial subjects in the event of trial related injuryd) All of the above d) All of the above a) Provide indemnification
c) That the drug will be safe in pregnant women and children
With regard to access to medical records during a clinical triala) The subject should consent in writing to medical record accessb) Access should be guaranteed for monitoring, audits, IRB review and regulatory inspectionc) Access should be in accord with prevailing federal and state lawsd) All of the above d) All of the above a) The subject should consent in writing to medical record access
f) Participate in the meetings between the investigator and staffg) Contribute to the investigator’s recruitment effortsh) Failed visits, test and procedures not performed are reported on CRFs e) CRFs are accurate and supported by sourced documents f) Participate in the meetings between the investigator and staff
The monitoring report should includea) Name of the investigatorb) Significant findings, deviations and deficienciesc) Actions needed to secure complianced) All of the above d) All of the above a) Name of the investigator
a) Regulatory authority should not routinely request access to the audit report With regard to access to the sponsor’s audit report by regulatory authority ICH advisesa) Regulatory authority should not routinely request access to the audit reportb) Require the audit report to be part of he study binderc) Ask to see the internal audit reports prior to commencing their audits d} Record the absence of an internal audit report a deficiency
Toxicological effects in the investigator’s brochure should includea) Carcinogenicityb) Irritancyc) Reproductive toxicityd) Genotoxicity and mutagenicitye) All of the above e) All of the above a) Carcinogenicity
d) Potential costs of the clinical trial.
d) Severe hallucinations caused by the ingestion of a recreational drug Which of the following would not be classified as an SAE?a) An anaphylactic event which needed an emergency room visitb) An acute renal failure, which resulted in an increased hospitalization stay of one dayc) A stroke which occurred during a clinical triald) Severe hallucinations caused by the ingestion of a recreational drug
In response to new preclinical studies a sponsor revises the Investigator’s Brochure which leads to changes in the inclusion and exclusion criteria and informs the Pl of these changes. The Pl or CRC shoulda) File an amendment to the IRB detailing the changeb) Make revisions in the informed consentc) Reconsent existing enrolled subjectsd) All of the above d) All of the above a) File an amendment to the IRB detailing the change
a) The person noted in the consent form for such contact The person who the subject should contact for research subject rights isa) The person noted in the consent form for such contactb) A person other than the principal investigatorc) Usually an IRB appointed Research Subject Advocate described in the consent formd) All of the above
d) The person designated for contact for medical matters on the consent form The person who should be contacted regarding a medical emergency experienced at home by a clinical trial subject isa) Always the principal investigatorb) The sponsor’s medical safety officerc) The research coordinatord) The person designated for contact for medical matters on the consent form
d) You need not concern yourself about whether you are receiving the drug or a sugar pill as we cannot tell you if the clinical trial has had any beneficial effect. The best way for a Pl to inform a subject about a placebo in a double-blind trial includes all of the following excepta) There is a fifty percent chance that you may be in a group that does not receive the investigational drugb) Because of the restrictions of the study I cannot tell you if you are in the group receiving drug or a sugar pillc) You will receive the same attention regardless of whether you are in the group receiving a drug or a sugar pilld) You need not concern yourself about whether you are receiving the drug or a sugar pill as we cannot tell you if the clinical trial has had any beneficial effect.
d) Conflict of interest information for core team members According to ICH all of the following are essential documents excepta) Delegation of authority formsb) Certificates of analysis for new batches of investigational drugsc) Normal values for the analytes being testedd) Conflict of interest information for core team members
b) Double-blind trial A clinical trial in which the only the research pharmacist knows the identity of the test article being given to subjects is aa) Single-blind trialb) Double-blind trialc) Open label triald) Crossover design trial
d) To the family physician for symptom management
An SAE experienced by a subject on a test drug for a clinical trial should be reported toa) Immediately to the sponsorb) To the regulatory agency within 7 calendar daysc) To the IRB usually in five days or sooner depending on institutional policyd) All of the above d) All of the above a) Immediately to the sponsor
d) All of the above a) Reading the consent form tothe subject
b) The signature of a legal guardian “A medically competent subject who has recently undergone physical injury in an accident to his writing hand signs the consent form with an “”x”” The consent process should includea) An impartial witnessb) The signature of a legal guardianc) A medical counselord) The signature of a family member”
a) Phase I About 15 subjects were enrolled in a clinical trial. The trial is most likelya) Phase Ib) Phase IIc) Phase IIId) Phase IV
A clinical trial requires five CT scans in the period of one year. For the disease condition only one CT scan per year is indicated . The situation requiresa) The radiation safety committee evaluation and approval prior to IRB approvalb) Statement about radiation risk in the consent formc) A consideration of an alternative imaging technique if possible.d) All of the above d) All of the above a) The radiation safety committee evaluation and approval prior to IRB approval
A subject being screened for a clinical trial of a drug for allergic rhinitis presents with a heart rate of 110 beats per minute. Tachycardia is not an exclusion criterion for the study. The CRC shoulda) Ask the sponsor’s medical safety officer if the subject should be enrolledb) Do a repeat measurement of heart rate, in two weeks or more, to see if the symptom is repeatablec) Ask the subject if he has experienced any symptoms of a rapid heart beatd) All of the above d) All of the above a) Ask the sponsor’s medical safety officer if the subject should be enrolled
During the course of a clinical trial the CRC notices that the Hct values have been consistently low in several subjects. Upon further investigation it was discovered that the lab assistant was storing the samples under his desk and sending the entire batch for analysis once every week. The CRC shoulda) Immediately inform the Plb) File a protocol deviation with the IRBc) Inform the sponsord) Arrange to have the lab assistant retrained or disciplinede) Initiate a CAPA planf) All of the above f) All of the above a) Immediately inform the Pl
d) File an unanticipated event report with the IRB A CRC has scheduled a first visit for a subject for an IRB approved study. When the patient arrives the CRC notices that the IRB approval letter is missing a date. The CRC should do all of the following excepta) Reschedule the visitb) Contact the IRB and ask for a dated letterc) Inform the Pld) File an unanticipated event report with the IRB
d) Children with lymphoma who have failed standard treatment A phase I oncology study for lymphoma in children should enrolla) Healthy adultsb) Healthy childrenc) Children with any known cancerd) Children with lymphoma who have failed standard treatment
The features of a source document should include their beinga) Attributable and legibleb) Contemporaneousc) Original and accurated) All of the above d) All of the above a) Attributable and legible
In conducting an audit of source documents the auditor would look fora) Original entries that were clearly visible, including alterationsb) Traceable or attributable documentsc) An audit trail of access to or alteration of the source documentsd) All of the above d) All of the above a) Original entries that were clearly visible, including alterations
For a CRC to file SAE reports to the IRB it would be advised thata) The CRC is a qualified physicianb) The CRC is delegated this function in the investigators’ delegation logc) This function be approved by the sponsor and the IRBd) All of the above d) All of the above a) The CRC is a qualified physician
a) Two years post marketing approval Clinical trial records should be preserved for at leasta) Two years post marketing approvalb) Two years post study closurec) Four years after the filing of marketing applicationd) As long as sponsor wants
d) Conduct a root cause analysis If a sponsor finds in an audit an action of the investigator which compromises human subject protection or reliability of the trial the sponsor shoulda) Immediately terminate the investigator’s involvementb) Notify the regulatory agencyc) Notify the IRBd) Conduct a root cause analysis
If a potential subject cannot speak or write English and an informed consent conference has to be held the investigator shoulda) Request the appropriate foreign language form from the sponsorb) Follow IRB procedures, including the use of a consent short form of the foreign languagec) Utilize a qualified and certified interpreter for the communication of the foreign language consent formd) All of the above d) All of the above a) Request the appropriate foreign language form from the sponsor
d) Record and report the episode as an adverse event to the sponsor A patient with a history of migraines in a clinical trial reports a migraine episode of greater frequency than usuals the investigator shoulda) Report the event as an SAE to the IRBb) Notify the sponsor of an SAE and do so promptlyc) Neither report nor record the eventd) Record and report the episode as an adverse event to the sponsor
An SAE is a medical event associated witha) Deathb) Life threatening eventc) Hospitalization or increased hospitalization stayd) All of the above d) All of the above a) Death
At a site initiation visit the sponsors CRA reviewsa) The protocolb) The schedule of assessments and associated CRFsc) The site’ SOPsd) All of the above d) All of the above a) The protocol
d) Source document verification The monitor is responsible fora) Verifying conflict of interest information on the part of the investigatorb) Facilitating recruitment at the sitec) Assisting the local CRC in scheduling patientsd) Source document verification
d) Number of members voting for, against and abstaining from the motion IRB minutes should recorda) Number of members voting for and against the motionb) Names of members voting for and against the motionc) Names of members voting for, against and abstaining from the motiond) Number of members voting for, against and abstaining from the motion
c) Only the voting member can count towards the quorum If a regular voting member and his alternate both attend the meeting thena) Only the voting member can present the studyb) Only the voting member can participate in the motionc) Only the voting member can count towards the quorumd) Only the voting member can be shown as attending the meeting in the minutes
c) Summary of the discussion of controverted issues The minutes of the IRB meeting should recorda) A detailed account of the discussion for every studyb) The reasons for members voting against the motionc) Summary of the discussion of controverted issuesd) An account of the scientific evaluations for each study
d) Any issue that caused a debate among the members A controverted issue is one in whicha) There was a tie vote for the studyb) One or more members abstained from the votec) A motion to defer the study was approvedd) Any issue that caused a debate among the members
d) All of the above a) Scientific evaluations that accompany each proposal
The minutes of the IRB meeting should include sufficient detail to show attendance. In practice this involves showinga) The names of the attendees and their representative rolesb) The earned degrees of the members attendingc) The alternate members and who they are the alternates ford) All of the above d) All of the above a) The names of the attendees and their representative roles
During a meeting a voting member has a conflict of interest for a study being reviewed. The minutes must indicatea) The name of the conflicted memberb) The name of the alternate who substituted for the conflicted member if applicablec) The study for which the conflict was recordedd) All of the above d) All of the above a) The name of the conflicted member
c) Three years The IRB records must be maintained for how long after the completion of the researcha) One yearb) Two Yearsc) Three yearsd) Five years
a) Research proposals reviewed, approved consent documents, continuing review activities and significant new findings provided to subjects IRB records must includea) Research proposals reviewed, approved consent documents, continuing review activities and significant new findings provided to subjectsb) Significant new findings provided to subjects, conflict of interest documents, continuing review activities, progress reports submitted by investigatorsc) Financial disclosure forms, reports of FDA audits of the studies, conflict of interest documents, reports of injuries to subjectsd) Significant new findings provided to subjects, conflict of interest documents, scientific evaluations of studies, reports of FDA audits
d) Adequate documentation of IRB activities The IRB staff should maintaina) Complete copies of all IRB activitiesb) Copies of all external audits of the IRBc) Financial records of IRB charges to sponsors for IRB reviewsd) Adequate documentation of IRB activities
d) The basis for requiring changes in or disapproving the research The IRB minutes should containa) Records of the scientific evaluations of the studies presentedb) Reasons behind the votes for abstentionc) Reasons behind a tie voted) The basis for requiring changes in or disapproving the research
c) Not participate in the initial discussion or vote for the study An IRB member with a conflict of interest shoulda) Not participate in the discussion of the study in questionb) Not participate in vote for the study in questionc) Not participate in the initial discussion or vote for the studyd) May be present if the IRB chair overrules the conflict of interest consideration
a) Ensure protective measures relevant to the population When reviewing studies involving a vulnerable population the IRB shoulda) Ensure protective measures relevant to the populationb) Appoint a subject advocate for the vulnerable groupc) Require continuing reviews more frequently than annuallyd) Mandate post approval monitoring for such studies
d) Be sufficiently qualified through the experience and expertise of its members The IRB shoulda) Have a physician as the IRB chairb) Have at least one member who is an attorneyc) Have specialists in the areas which it might reviewd) Be sufficiently qualified through the experience and expertise of its members
d) Consider a diversity of membership in race, gender, cultural backgrounds In terms of earning the respect for its advice and counsel from the community the IRB shoulda) Consider a highly educated membershipb) Consider only those individuals who are members of professional societiesc) Consider the inclusion of one or more attorneysd) Consider a diversity of membership in race, gender, cultural backgrounds
c) Individuals who are knowledgeable and experienced in working with these groups In frequently reviewing studies involving vulnerable subjects the IRB should consist ofa) Community members sympathetic to these groupsb) Attorneys who specialize in legal issues that pertain to these groupsc) Individuals who are knowledgeable and experienced in working with these groupsd) Subject advocates for each vulnerable group
c) Invite competent consultants but not have them vote When reviewing studies in specialized areas the IRB shoulda) Consider written review only from outside consultantsb) Rely on the expertise of its voting members and need not use consultantsc) Invite competent consultants but not have them vote d) Invite consultants and include them in the vote
d) Follow state law if it provides more stringent protections than federal law. In reviewing matters of state law the IRB shoulda) Appoint a lawyer certified to practice in the state as a memberb) Get advice form OHRP on state law mattersc) Follow the federal guidelines regardlessd) Follow state law if it provides more stringent protections than federal law.
c) Appoint approved matching alternates for this member The IRB has a non-scientific member whose attendance at meetings is erratic and leads to loss of quorum. The IRB may address this situation bya) Firing the non-scientific memberb) Meet without the memberc) Appoint approved matching alternates for this memberd) Write institutional policy for disciplining unruly IRB members
a) One physician present An IRB reviewing an IND study must according to FDA guidelines have at leasta) One physician presentb) A specialist in the study topic presentc) A community member presetd) Only the nonscientific member present
d) All of the above An IRB must maintain written procedures fora) Conducting initial and continuing reviewb) Determining which projects require review more often than annuallyc) Ensuring prompt reporting of proposed changes in researchd) All of the above
Actions that the IRB can take when reviewing a study area) Approveb) Approve with conditionsc) Defer pending major modificationsd) Disapprovee) All of the above may apply e) All of the above may apply a) Approve
d) All of the abovea) Make specified changes to the protocolb) Make specified changes to the informed consentc) Submit specific clarifications or specified additional documents The decision to approve with conditions implies:a) Make specified changes to the protocolb) Make specified changes to the informed consentc) Submit specific clarifications or specified additional documentsd) All of the above
The IRS may not approve a study if it is unablea) To make determinations about research risksb) To determine the adequacy of privacy and confidentiality agreementsc) To determine the adequacy of the informed consent or the informed consent processd) All of the above d) All of the above a) To make determinations about research risks
d) The research may not proceed until reviewed again and approved by a fully convened IRB. When an IRB defers a research project:a) The research can proceed in the interimb) The research may not proceed until reviewed by the IRB chairc) The research may not proceed until reviewed by a qualified consultant to the IRSd) The research may not proceed until reviewed again and approved by a fully convened IRB.
d) Disapprove the study
d) Submission of additional specified documents
d) Changes in the exclusion criteria for the study
d) A fully convened IRB except
b) Approve the study with the condition An IRB reviewing a study of surgical procedures requires that a change be made in the protocol to ensure that the informed consent is done at a prior clinical visit and not be scheduled on the day of the surgery. The action taken by the IRB would bea) Approve the study with the optional recommendationb) Approve the study with the conditionc) Defer the studyd) Disapprove the study
b) Approve the study with the condition An IRB reviewing a study which requires radiographic imaging requires the investigator to confirm that the contrast agent used in the imaging be confined to the type and dose of the reagent specified by the IRB. The action taken by the IRB should bea) Approve the study with the optional recommendationb) Approve the study with the conditionc) Defer the studyd) Disapprove the study
b) Approve the study with the condition An IRB reviewing a study requires the investigator to obtain a certificate of confidentiality and a letter of approval from the radiation safety committee. The action taken by the IRB would bea) Approve the study with the optional recommendationb) Approve the study with the conditionc) Defer the studyd) Disapprove the study
b) Approve the study with the condition An IRB reviewing a study requires the investigator to specify which procedures are standard of care and which are research related. The action taken by the IRB would be:a) Approve the study with the optional recommendationb) Approve the study with the conditionc) Defer the studyd) Disapprove the study
c) The date of approval by the IRB chair An IRB recommends that a research study be approved with conditions. The investigator submits the revised study and it is approved by the IRB chair. The approval date for the study would bea) The date of the initial reviewb) The date of submission of the revision by the investigatorc) The date of approval by the IRB chaird) The date the letter of approval is mailed out.
c) Defer the study An IRB reviewing a study requires the investigator to replace the placebo group with a comparator drug. The likely action taken by the IRB would bea) Approve the study with the optional recommendationb) Approve the study with the conditionc) Defer the studyd) Disapprove the study
a) Approve the study for adults and defer the study for children An IRB reviews a study which has two treatment groups one involving adults over the age of 18 and the other involving children under the age of 18. The IRB has reservations about the adequacy of the protocol for the inclusion of children. The IRB maya) Approve the study for adults and defer the study for childrenb) Approve the study with conditions for both groupsc) Disapprove the study for both groups since one group does not qualifyd) Defer the study for both groups.
a) Approve the study to prevent disruption of the research protocol
When an IRB approves a study with conditions the IRB musta) Document the date of the acceptance of the changes by the IRB reviewer, the date of approval if different from this date and the date of continuing reviewb) Document conditions for partial approval with conditionsc) Document all appropriate events and reviews in the minutes and IRB recordsd) All of the above.
a) Whether the event occurred in the time frame of drug administration The most important consideration in reporting and adverse event in a clinical trial isa) Whether the event occurred in the time frame of drug administrationb) Whether the event is reported as drug related by the research subjectc) Whether the event is listed as an adverse event in the investigator’s brochured) Whether the event is listed as an adverse event in the protocol.
d) Protection of subject safety Timely and accurate reporting of an adverse event is most important fora) Ensuring drug approval by the regulatory agencyb) Prevention of study suspension by the IRBc) Updating the consent formd) Protection of subject safety
a) Report the event to the sponsor and the IRB A research subject enrolled in a clinical trial is involved in a car accident and suffers significant physical injuries. The event occurs while the drug administration phase of the protocol is still ongoing. The investigator shoulda) Report the event to the sponsor and the IRBb) Not report the eventc) Report the event to the REGULATORY AGENCYd) Report the event to OHRP
a) The principal investigator A research subject enrolled in a clinical trial experiences significant chest pain and is admitted to the emergency department for the possible evaluation of a cardiac event. The event occurs while the drug administration is still ongoing in the clinical trial. The causality of the event should be determined bya) The principal investigatorb) The study sponsorc) The IRBd) The subject’s personal physician
a) Serious, unanticipated and possibly related to the drug The sponsor must report a serious adverse event in an IND safety report to the regulatory agency if the event isa) Serious, unanticipated and possibly related to the drugb) Serious regardless of anticipatedness or proof of relatednessc) Mentioned as a high risk event in the investigator’s brochured) Stated in the informed consent
d) Report the event to the study sponsor and the IRS A research subject in clinical trial under IND experiences difficulty breathing and self admits to the emergency department. The investigator shoulda) Submit the SAE report to the sponsor onlyb) Not report the event as the admission to the emergency department was self-reportedc) Report the event to the IRS but not the study sponsord) Report the event to the study sponsor and the IRS
a) The REGULATORY AGENCY and the IRB Reporting a health related adverse event in clinical trial as serious, unanticipated and possibly related are criteria required bya) The REGULATORY AGENCY and the IRBb) OHRPc) The sponsor’s instruction to the investigatord) The subject’s personal physician
a) Subject A “In clinical trial under an IND Subject A experiences difficulty breathing and self admits to the emergency room. Subject S experiences nausea and vomiting which is resolved by home rest for a day. Which event should be reported as “”serious”” to the regulatory agency?a) Subject Ab) Subject Sc) Subjects A and Sd) Neither subject.”
a) Any adverse event observed in the subject In a clinical trial, reports of adverse events from the investigator to the sponsor should includea) Any adverse event observed in the subjectb) Only events which meet the definition of a serious eventc) Only events which are unanticipatedd) Only events which meet the definition of possibly related to drug
For an adverse event to be characterized as unexpected OHRP guidance advises that the event should be in nature, severity or frequency bea) Not listed in the research protocolb) Not listed in the informed consentc) Not a characteristic of the study populationd) All of the above d) All of the above a) Not listed in the research protocol
According to OHRP guidance corrective actions which may be needed in response to an unexpected problem includea) Modification of the research protocol including eligibility criteriab) Modification of informed consent and reconsent of currently enrolled subjectsc) Suspension of new enrollment and of current procedures in enrolled subjectsd) All of the above. d) All of the above. a) Modification of the research protocol including eligibility criteria
a) His action is approvable under regulations In a clinical trial under an IND the investigator determines that a protocol procedure should be changed immediately in consideration of patient safety. He does not inform the IRB or the sponsora) His action is approvable under regulationsb) His action constitutes serious noncompliancec) His action merits study suspensiond) His action merits disciplinary action from the institution
c) Physical and psychological harms Adverse events encompassa) Physical harms onlyb) Psychological harms onlyc) Physical and psychological harmsd) Harms determined as relevant and serious by the investigator.
d) Unexpected, possibly related to participation and places the subject or others at a greater risk of harm than previously recognized. According to OHRP an adverse event represents and unanticipated problem if it isa) Unexpected, possibly related to participationb) Unexpected and meets the REGULATORY AGENCY definition of seriousc) Possibly related to participation even if expectedd) Unexpected, possibly related to participation and places the subject or others at a greater risk of harm than previously recognized.
An adverse event is defined as serious if it isa) Death or life threatening eventb) Results in hospitalization or prolongation of a hospitalizationc) Results in a persistent or significant disabilityd) Results in a congenital anomaly or birth defecte) Any of the above e) Any of the above a) Death or life threatening event
d) The investigator, the sponsor, the coordinating center and the DSMB. With regard to obtaining continued approval of a clinical trial the IRB has the authority to require additional detailed information froma) The investigator onlyb) The investigator and the sponsorc) The study coordinating centerd) The investigator, the sponsor, the coordinating center and the DSMB.
b) One week According to OHRP guidance unanticipated problems which are serious should be reported to the IRB withina) One dayb) One weekc) Two weeksd) One month
c) Two weeks According to OHRP guidance unanticipated problems which are other than serious should be reported to the IRB withina) One dayb) One weekc) Two weeksd) One month
a) Promptly In a clinical trial a serious adverse event should be reported by the investigator to the sponsor withina) Promptlyb) Seven daysc) Fifteen daysd) One month
With respect to monitoring of adverse events in a clinical trial the IRB should considera) The type of data, events and the entity responsible for reportingb) The time frame and frequency of assessments of events and their relationship to stopping rulesc) The appropriate procedures for timely communication of the monitoring results to the IRB and sponsord) All of the above d) All of the above a) The type of data, events and the entity responsible for reporting
In order to distinguish an event as being probably versus possibly related to a drug it is important to eliminatea) Natural progression of disease or disease related eventsb) Contributions from concomitant medicationsc) Both a and bd) Neither a nor b c) Both a and b a) Natural progression of disease or disease related events
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations An investigator conducting a study of illicit drug behavior has the data on a laptop in an unencrypted fashion. The laptop is stolen. The event isa) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulationsb) Adverse event that does not represent an unanticipated problem and does not need tobe reported under DHHS regulationsc) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulationsd) DHHS regulations do not apply
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations A pharmacist makes a dosing error in a clinical trial that results in no harm to any subject.The event isa) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulationsb) Adverse event that does not represent an unanticipated problem and does not need tobe reported under DHHS regulationsc) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulationsd) DHHS regulations do not apply
a) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulations Subjects in a cancer trial received serum that was not screened for the hepatitis virus. No illness in subjects is reported. The event isa) Unanticipated problem that does not involve an adverse event and needs to be reported to the IRB under regulationsb) Adverse event that does not represent an unanticipated problem and does not need tobe reported under DHHS regulationsc) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulationsd) DHHS regulations do not apply
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations A subject in an oncology trial develops multi organ failure and dies. The event is a known complication of the disease and standard therapy and is described in an IRB approved protocol.The event isa) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulationsb) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulationsc) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulationsd) DHHS regulations do not apply
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations A subject in a psychology study requires sequestration in small space and develops claustrophobia which is described as one of the risks in the IRB approved protocol. The event isa) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulationsb) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulationsc) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulationsd) DHHS regulations do not apply
b) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulations An investigator carries out prospective chart reviews of neonates in the intensive care unit.One of the neonates dies. The event isa) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulationsb) Adverse event that does not represent an unanticipated problem and does not need to be reported under regulationsc) Adverse event that does represent an unanticipated problem that needs to be reported under DHHS regulationsd) DHHS regulations do not apply
c) Adverse event that does represent an unanticipated problem that needs to be reported under regulations A subject in clinical trial for GI reflux disease develops renal failure, an event not described in the protocol or informed consent. The event isa) Unanticipated problem that does not involve an adverse event and needs to be reported under DHHS regulationsb) Adverse event that does not represent an unanticipated problem and does not need to be reported under DHHS regulationsc) Adverse event that does represent an unanticipated problem that needs to be reported under regulationsd) Regulations do not apply
a) Report all serious events to the DSMB With regard to reporting serious adverse events to the DSMB the sponsor shoulda) Report all serious events to the DSMBb) Forward only the IND safety reports sent to the REGULATORY AGENCY to the DSMBc) Forward only the events reported to the IRBd) Forward only the events to be reported to the funding agency
A protocol deviation isa) Any departure from the procedures and practices described in an IRB approved protocolb) Any action associated with regulatory non-compliancec) Failure to follow the appropriate procedure or protocol for the informed consent processd) All of the above. d) All of the above. a) Any departure from the procedures and practices described in an IRB approved protocol
A pharmacist providing an investigational drug for a Phase I protocol makes an error in the dosing which is not associated with any adverse event in the subject. The event isa) A protocol deviationb) An unanticipated event of risk to self or othersc) Both a and bd) Neither because it is not a serious adverse event c) Both a and b a) A protocol deviation
a) A protocol deviation A subject in an IND protocol misses a study visit because of a work related engagement and shows up for the scheduled visit two days after the due date. There are no medical consequences. The event isa) A protocol deviationb) A serious adverse eventc) An unanticipated event of risk to self or othersd) Regulatory non-compliance
a) Missed or late study visit because of patient non-compliance One of the most common protocol deviations isa) Missed or late study visit because of patient non-complianceb) Missed or late study visit because of mistakes in scheduling of the Plc) Drug dose related miscalculationsd) Failure to maintain a delegation of authority log for the clinical trial.
A high risk protocol deviation would be one witha) High risk to patientb) High risk to the studyc) Both a and bd) High risk to the institution c) Both a and b a) High risk to patient
b) Part of study monitoring, immediately remediable and not reportable to the IRB During a study monitoring visit the monitor observes the following documents are incomplete or missing: the investigator’s CV, the delegation of authority log, IRB approval letters. This should bea) Reported as a protocol deviationb) Part of study monitoring, immediately remediable and not reportable to the IRBc) Reportable as an adverse event to the sponsord) An unanticipated event reportable by the IRB to OHRP.
c) A protocol deviation that is also a serious adverse event In a study under an IND involving an oral drug the subject misses two doses and takes an extra-large dose on the third day to make up for the missed doses. She suffers a serious medical event which needs hospitalization. The vent isa) A protocol deviation onlyb) A serious adverse event onlyc) A protocol deviation that is also a serious adverse eventd) Not reportable because this is a patient error and not an investigator error.
In a study under an IND an investigator enrolls a patient without informed consent which is done after the patient’s first visit. Later the informed consent undergoes a change which requires reconsent. The investigator fails to obtain reconsent. The event isa) A protocol deviationb) Serious or continuing non-compliancec) Both a and bd) Not reportable because such an event is not described in the DHHS regulations c) Both a and b a) A protocol deviation
b) Part of study monitoring, immediately remediable and not reportable to the IRB During a study monitoring visit the study monitor observes several errors in the case report forms and a failure to attach source documents in support of the data recorded. The event should bea) Reported as a protocol deviationb) Part of study monitoring, immediately remediable and not reportable to the IRBc) Reportable as an adverse event to the sponsord) An unanticipated event reportable by the IRB to OHRP.
a) Is itself a protocol deviation Late reporting of a protocol deviationa) Is itself a protocol deviationb) Is a serious adverse eventc) Is of no consequence because DHHS regulations do not specify a time period for reporting protocol deviationsd) Is an event of interest only to the sponsor
d) Follow the sponsor’s instructions and report it to the IRB. During a study monitoring visit the study monitor observes that the revised versions of the investigator’s brochure are not being kept in the regulatory binder for the study. The sponsor asks the investigator to report this as a protocol deviation to the IRB. The investigator shoulda) Not report it because it is not within institutional guidelines for a protocol deviationb) Not reportable because it was corrected by the investigatorc) Not reportable because it is a minor event of no risk to patient or studyd) Follow the sponsor’s instructions and report it to the IRB.
a) Protocol deviation During the study monitoring visit it was noted that the sample for laboratory analysis were being shipped long after the required shipment date. Many of the samples were deemed non evaluable. The event isa) Protocol deviationb) Serious adverse eventc) An unanticipated event of risk to self or othersd) Nor reportable because the lab measurements were not of central importance to the study outcome.
Laboratory related protocol deviations can includea) Improper lab sample collectionb) Improper shipment of a lab sample which results in a non-evaluable sample.c) Improper storage of the sample prior to shipmentd) Shipment of the sample by non-certified personnele) Any of the above. e) Any of the above. a) Improper lab sample collection
During a study under an IND the investigator places the data on a lap top and the lap top is stolen. The data was not encrypted. The event isa) Protocol deviationb) Unanticipated event of risk to self or othersc) Both a and bd) Serious adverse event c) Both a and b a) Protocol deviation
a) Reported to the IRB on forms designated for such reports A protocol deviation should bea) Reported to the IRB on forms designated for such reportsb) Reported directly to OHRP by the investigatorc) Reported to the FDAd) Not reportable as this is not addressed in DHHS regulations.
A protocol deviation should be reported to the IRBa) Promptlyb) Within the prescribed institutional guidelinesc) Both a and b may applyd) According to the investigator’s convenience as the time period is not specified in DHHS regulations. c) Both a and b may apply a) Promptly
d) Develop a comprehensive Corrective and Preventive Action Plan (CAPA plan) When a protocol deviation is observed on several occasions the investigator shoulda) Batch the reporting of the protocol deviations for reporting to the IRBb) Report it directly to institutional officialsc) Report it to the IRB only after it has been correctedd) Develop a comprehensive Corrective and Preventive Action Plan (CAPA plan)
The essential elements of a Corrective and Preventive Action Plan (CAPA plan) developed in response to repeat protocol deviations might includea) Root cause analysisb) Training and education needs to ensure repeat events do not occurc) System changes to ensure future preventiond) All of the above. d) All of the above. a) Root cause analysis
a) If the event is associated with a serious adverse event Protocol deviations are reportable to the FDAa) If the event is associated with a serious adverse eventb) Routinelyc) Only if the OHRP recommends itd) Never
d) Ensure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. Regulations provide which of the following guidelines regarding data monitoringa) Specific guidelines for data and safety monitoring boardb) Describes the need of a DSMB in the review of serious adverse eventsc) Guidelines that the IRB may substitute for a DSMB if the conditions require it.d) Ensure that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
c) Sponsor An independent DSMB for a clinical trial reaches a decision communicated in its report that the clinical trial be stopped for safety. The DSMB report should be sent toa) FDAb) IRBc) Sponsord) OHRP
c) Safety and efficacy at defined intervals DSMB’s primary responsibility is to reviewa) Protocol deviationsb) The informed consentc) Safety and efficacy at defined intervalsd) Monitoring data quality and integrity
c) DSMB The decision to stop a Phase 2 or Phase 3 trial at all sites is the responsibility ofa) FDAb) IRBc) DSMBd) The investigator at the coordinating center
d) The relative duties of the DSMB and the IRB are described in regulations
a) Choose to delegate evaluations of safety at the site to the principal investigator The sponsor in a phase 2 clinical trial maya) Choose to delegate evaluations of safety at the site to the principal investigatorb) Carry out all evaluations of SAEs itselfc) Delegate the evaluation of SAEs to the CROd) Choose not to report an SAE to the FDA
The frequency of meetings of the DSMB may bea) Based on a specified frequency in time (every six or twelve months for example)b) Based on the number of serious adverse events observedc) Based on the number of patients enrolledd) All of the above. d) All of the above. a) Based on a specified frequency in time (every six or twelve months for example)
The FDA guidance on an independent DSMB states that the sponsor should consider one for a clinical trial if the trial isa) Multisite and phase 3b) Involves a vulnerable populationc) Has a complex designd) Is pivotal for study outcomee) All of the above. e) All of the above. a) Multisite and phase 3
a) Conflict of interest with the principal investigator A major problem in the DSMBs for a sponsor- investigator clinical trial isa) Conflict of interest with the principal investigatorb) Unavailability of qualified membersc) Difficulty in IRB approval of the DSMB membersd) Difficulty in convening the DSMB and keeping minutes
a) Pl to CRO to sponsor to DSMB In a sponsored clinical trial the path to reporting serious adverse events isa) Pl to CRO to sponsor to DSMBb) Pl to CRO to DSMBc) Pl to DSMBd) Pl to IRB to DSMB
a) Must suspend the clinical trial at its site If the DSMB suspends a clinical trial the IRBa) Must suspend the clinical trial at its siteb) May still keep the trial open if it deems the trial is importantc) May postpone the decision to suspend until it observes what the DSMB has observedd) May suspend new enrollment but permit continued treatment of current subjects.
c) Stop new enrollment and treatments and keep the study open only for long term follow up of existing subjects When the DSMB suspends a clinical trial it is customary for the principal investigatora) To keep the commitment to treat new enrollees because they have signed the informed consentb) Keep the treatment schedule for currently enrolled subjectsc) Stop new enrollment and treatments and keep the study open only for long term follow up of existing subjectsd) Ignore the dictates of the DSMB as it does not know the events at the site in any detail.
d) World Medical Association The Declaration of Helsinki was formulated by thea) National commission for the protection of human subjectb) Council for the international organization of medical sciencesc) The War Crimes Tribunald) World Medical Association
d) The Declaration of Helsinki Which of the following ethical frameworks has been revised on several occasions?a) The Belmont reportb) The Nuremberg Codec) ICH-GCPd) The Declaration of Helsinki
The Declaration of Helsinki contains which of the following items:a) In medical research most procedures involve risks and burdensb) The welfare of animals must be respectedc) Medical research is justified only if there is likelihood that the research populations stand to benefit from the results of the researchd) Medical research should only be carried out if the importance of the objective outweighs the inherent risks to the subjectse) Negative as well as positive results should be published or made publicly available.f) Post-trial provision of a beneficial treatment should be provided with the relevant information to study participantsg) All of the above f) Post-trial provision of a beneficial treatment should be provided with the relevant information to study participants
b) It may be appropriate to consult with family members or community leaders regarding the informed consent process d) The dependent relationship with a physician should be avoided in a consent situation e) The refusal of consent should not affect the patient physician relationship.
c) The researcher must provide monitoring information to the committee especially information about any serious adverse events Regarding the reporting of serious adverse events which of the following statements is included in the Declaration of Helsinki:a) Serious adverse events need to be reported only if they are unanticipated and possibly related to the research.b) The data and safety monitoring board should send reports directly to the research ethics committeec) The researcher must provide monitoring information to the committee especially information about any serious adverse eventsd) The research ethics committee should review all adverse events from all participating sites in a clinical trial.
Regarding the use of placebos in clinical trials the Declaration of Helsinki states thata) The benefits risks and burdens of a new intervention must be tested against the best proven intervention.b) Placebo may be used when for sound methodological reasons it is important to determine safety and efficacy of the interventionc) The use of placebo will not result in additional risks of serious or irreversible harm to the subject relative to not receiving the best possible interventiond) All of the above
d) When medical research is combined with medical care, additional standards apply to protect the research subjects. With regard to the role of medical care in medical research the Declaration of Helsinki notes:a) Consent for the medical care is not separately requiredb) Medical care and medical research should be kept separable as much as possiblec) Procedures for medical research but not medical care should be described in the informed consentd) When medical research is combined with medical care, additional standards apply to protect the research subjects.
c) Distribution of burdens and benefits The principle of justice in the Belmont report relates toa) Payment to subjectsb) Protection of vulnerable subjectsc) Distribution of burdens and benefitsd) Compensation for injuries
a) Decision on the part of subjects to voluntarily participate or not in the research Respect for persons in the Belmont report relates toa) Decision on the part of subjects to voluntarily participate or not in the researchb) Protection from harmsc) Sharing benefits with othersd) Legal protection in the event of medical injury
c) Nuremberg war crimes trial involving Nazi medical experiments Which of the following is cited as an influence in the Belmont Report?a) The Milgram studyb) The tea room trade studyc) Nuremberg war crimes trial involving Nazi medical experimentsd) The Guatemala Syphilis study
d) Tuskegee study Which of the following is cited in the principle of justice as exemplifying an injustice?a) The Willowbrook studyb) The San Antonio Contraception studyc) The Radiation experimentsd) Tuskegee study
a) Respect for persons If an investigator does not obtain consent from his subjects the principle in Belmont that is violated isa) Respect for personsb) Principle of justicec) Beneficenced) Privacy and confidentiality
c) Respect for persons, beneficence, justice The three principles in the Belmont report relate toa) Privacy, confidentiality, conflict of interestb) DHHS regulations, IRB procedures, FDA guidance’sc) Respect for persons, beneficence, justiced) Informed consent, Debriefing forms, deception
c) Risk benefit ratio The IRB should refer to the principle of beneficence in the Belmont report when it is evaluatinga) Payment to subjectsb) Study populationsc) Risk benefit ratiod) Informed consent
c) Differences between practice and research The Belmont report addressesa) Compensation for medical injuryb) Guidelines for conflict of interestc) Differences between practice and researchd) Disclosure of incidental findings
a) The National Commission for the protection of human subjects in biomedical and behavioral research The Belmont report was formulated bya) The National Commission for the protection of human subjects in biomedical and behavioral researchb) The National Commission for protection of families in biomedical researchc) The National Commission for the medical protection of human subjects in researchd) The National Commission for the study of medical research of human subjects in biomedical and behavioral research
c) The National Research Act of 1974 The Commission that formulated the Belmont report was created as a part ofa) The National Research Act of 1985b) The Biomedical Research Act of 1977c) The National Research Act of 1974d) The National Commission of 1979
b) Investigator and FDA A 1572 is a contract betweena) IRB and FDAb) Investigator and FDAc) Sponsor and FDAd) Sponsor and institution
c) Given by the sponsor to the investigator According to FDA regulations the investigator brochure must bea) Given by the sponsor to the IRBb) Given by the investigator to the IRBc) Given by the sponsor to the investigatord) Given by the sponsor to the CRO
d) Not enter into any financial arrangement with the sponsor e) Inform patients that the drugs are investigational
a) Submission of an updated 1572 Which of the following is an FDA mandated responsibility that represents the investigator’s responsibility to the sponsor?a) Submission of an updated 1572b) Completion of a delegation logc) Retention of records for three yearsd) Update the investigator’s CV annually
e) Financial disclosures of the principal investigator 1.1 All of the following items are required on a Form 1572 excepta) The principal investigator’s CVb) Information on sub investigatorsc) Laboratory facilities utilizedd) IRB informatione) Financial disclosures of the principal investigator
a) Form 1571 The investigator’s brochure is a central part of the submission of an INDa) Form 1571b) Form 1572c) Form 3455d) Med watch Form 3500 A
e) Financial disclosure of the sponsor
d) Off label use at the discretion of a physician An IND is needed for all of the following excepta) A new chemical entityb) A new or unapproved indicationc) A new dosage form or dosage level or new drug combinationd) Off label use at the discretion of a physician
e) A contemplated new marketing application except
d) The study will not adhere to an approved route of administration or dosage level.
d) Change in the IRB roster
a) Form 1571 The sponsor’s decision to use a CRO should be declared ina) Form 1571b) Form 1572c) Form 3455d) Medwatch Form 3500 A
c) Serious , unanticipated and possibly related For an adverse event to be reported to the FDA it must bea) Seriousb) Serious and unanticipatedc) Serious , unanticipated and possibly relatedd) Serious, unanticipated and probably related
d) With written permission from the FDA. A sponsor may charge a subject for an investigational druga) If the sponsor’s budget needs itb) If the drug is expensivec) If the institution agreesd) With written permission from the FDA.
c) Form 1571 and Form 1572 A sponsor investigator must complete the following forms for the FDA at the initiation of a clinical trial Ia) Form 1571 onlyb) Form 1572 onlyc) Form 1571 and Form 1572d) Medwatch form 3500 A
it d) File an IDE because is significant risk device.
d) When the device to be marketed is substantially equivalent to the current approved device. A 51Ok premarket notification is submitteda) When the device is a Class I device onlyb) Before the initiation of a clinical trailc) When the device is intended for population of less than 4000d) When the device to be marketed is substantially equivalent to the current approved device.
An IDE is required before a new devicea) Can be evaluated in a clinical trialb) Shipped across state linesc) Both a and bd) Neither a nor b c) Both a and b a) Can be evaluated in a clinical trial
b) Class II devices An MRI machine and a thermometer are examples ofa) Class I devicesb) Class II devicesc) Class 111 devicesd) Class IV devices
d) An IRB SR/NSR determination for a device An abbreviated IDE isa) A shorter IDE application to the FDAb) A variation on a 51OK applicationc) An alternative to the FDA IDE application processd) An IRB SR/NSR determination for a device
An HUD is a devicea) Applicable to less than 4000 individualsb) A device for which a clinical trial to prove effectiveness is not requiredc) For which no comparable device exists on the marketd) All of the above d) All of the above a) Applicable to less than 4000 individuals
d) May not use the device as it does not have an IRB. A small hospital without an IRB has an urgent need to use a HUD. The hospitala) May file for an HOEb) Use the device anywayc) Inform the FDA of its intent to use the deviced) May not use the device as it does not have an IRB.
A regulatory path to market for a device may includea) An IDEb) APMAc) A 510K applicationd) An HOEe) All of the above. e) All of the above. a) An IDE
a) Preclinical studies- IDE-PMA The sequence of regulatory events for approval of marketing for a device isa) Preclinical studies- IDE-PMAb) Preclinical studies- PMA-IDEc) 510K-IDE-PMAd) HDE-510K-PMA
d) Made by the IRB A non-significant risk determination for a study planned by an investigator isa) Made by the sponsorb) Made by the FDAc) Made by OHRPd) Made by the IRB
A significant risk device isa) Implantableb) Poses a serious risk to healthc) Mitigates a serious risk to subjectd) Essential for diagnosis , treatment or curee) All of the above. e) All of the above. a) Implantable
An IDE exemption may be granted ifa) The device has a 510Kb) The study uses an approved device on labelc) The device is a non-significant risk deviced) All of the above. d) All of the above. a) The device has a 510K
a) Serious An adverse event in a device study is reported to the FDA if it isa) Seriousb) Serious and unanticipatedc) Serious and unanticipated and possibly relatedd) Serious and unanticipated and probably related.
c) An investigator agreement An investigator participating in a device study must complete a) A 1572b) A1571c) An investigator agreementd) A form from Appendix M
d) A feasibility study followed by a pivotal study. The sequence of clinical trials for a device studya) Phase 1- 2-3-4b) Phase 1-2-3c) A single clinical triald) A feasibility study followed by a pivotal study.
d) Tend to be much smaller than in drug studies. Sample populations in device studiesa) Tend to be derived from a single siteb) Must have at least 100 subjectsc) Must be at least 1% of the target disease populationd) Tend to be much smaller than in drug studies.
a) Have review and approval from the IRB Before an HUD is used in a hospital the application musta) Have review and approval from the IRBb) Have institutional approvalc) Have only the sponsor’s approvald) Have an approved HOE from the FDA only
a) Collecting research data for effectiveness
c) Form 3455 Financial disclosure in clinical trial under an IND is done ona) Form 1571b) Form1572c) Form 3455d) Medwatch 3500 A
d) All of the above a) Disclosure of any financial arrangement
c) $25000 FDA requires the disclosure by the principal investigator of financial payments of an amount greater thana) $5000b) $10,000c) $25000d) $50000
c) $50000 FDA requires disclosure by the principal investigator of equity interest greater thana) $10000b) $25000c) $50000d) $75000
FDA requires disclosure by the principal investigator of proprietary interest which includesa) Patentsb) Copyright or trademarkc) Intellectual propertyd) All of the above d) All of the above a) Patents
FDA requires reporting of any financial interest of the principal investigator in the sponsora) Immediately before the trial beginsb) During the clinical trialc) For a period of one year after study closure at the site.d) All of the above d) All of the above a) Immediately before the trial begins
b) Need not disclose this to the FDA on Form 3455 The principal investigator in an IND study owns shares in a mutual fund that invests in the stock of the sponsor as one of its holdings. The investigatora) Must disclose this to the FDA on form 3455b) Need not disclose this to the FDA on Form 3455c) Must disclose this to the institutional conflict of interestd) Must disclose this on the consent form
a) Must disclose this to the FDA on form 3455 The principal investigator’s wife owns equity interest greater than $50,000 directly in the sponsor’s stock.The principal investigatora) Must disclose this to the FDA on form 3455b) Need not disclose this to the FDA on Form 3455c) Must disclose this to the institutional conflict of interest committeed) Must disclose this on the consent form
The principal investigator receives a cash payment for consultation from the sponsor in the amount of $10000. This amount isa) Below the threshold amount for disclosure to the FDAb) May have to be disclosed to the conflict of interest committeec) May have to be disclosed to the IRS if required by the institutional guidelinesd) All of the above. d) All of the above. a) Below the threshold amount for disclosure to the FDA
The conflict of interest committee reviewing the disclosure of a Pl on an FDA clinical trial in the amount of $10000a) May require the Pl to transfer consenting responsibilities to others on the research teamb) May require the Pl to transfer the principal investigator duties to the co-investigator who does not have a conflict of interestc) May develop a customized conflict of interest management plan specific to this situation.d) All of the above.
c) Are less than the FDA guidelines
a) Phase 1 The studies designed to first introduce a drug in human beings area) Phase 1b) Phase2c) Phase 3d) Phase 4
a) Phase 1 The studies with the highest risk to benefit ratio area) Phase 1b) Phase2c) Phase 3d) Phase 4
a) Phase 1 The studies with lowest number of subjects is likely to bea) Phase 1b) Phase 2c) Phase 3d) Phase 4
a) Phase 1 The studies most likely to use healthy volunteers are likely to bea) Phase 1b) Phase 2c) Phase 3d) Phase 4
d) Phase 4 The studies most likely to employ the use of a drug registry are likely to bea) Phase 1b) Phase 2c) Phase 3d) Phase 4
c) Phase 3 The studies most likely to influence the labeling of the drug and its approval by the FDA area) Phase 1 studiesb) Phase 2c) Phase 3d) Phase 4
d) Phase 4 studies The studies which do not require an IND area) Phase 1 studiesb) Phase 2 studiesc) Phase 3 studiesd) Phase 4 studies
d) Phase 4 The studies which are likely to have the longest duration area) Phase 1b) Phase 2c) Phase 3d) Phase 4
b) Phase 2 The studies which are likely to provide the earliest reliable information about efficacy area) Phase 1b) Phase 2c) Phase 3d) Phase 4
b) Phase 2 A study enrolls 100 subjects is most likely to bea) Phase 1b) Phase 2c) Phase 3d) Phase 4
A Phase 1 study is likely to evaluatea) DLT (dose limiting toxicity)b) MTD (maximum tolerated dose)C) Half -lifed) All of the above. d) All of the above. a) DLT (dose limiting toxicity)
d) 6.25 A drug has a half-life of one day and has an initial plasma concentration of 100 mg. The concentration after four days isa) 50b) 25c) 12.5d) 6.25
d) 4 days A drug has a half- life of one day and a Minimum Effective Concentration (MEG) of 12.5 mg. It has an initial concentration of 100 mg. The drug will stop being effective aftera) 1 dayb) 2daysc) 3 daysd) 4 days
b) 1 The minimum number of subjects that can be enrolled in a clinical trial isa) 0b) 1c) 10d) 100
d) Effects are unlikely at the lowest doses tested Phase 1 studies are likely to provide the least reliable data on efficacy becausea) They are always conducted in healthy subjectsb) They are not measuring efficacyc) They are too long in durationd) Effects are unlikely at the lowest doses tested
In order to avoid serious harm to subjects in phase 1 studiesa) The lowest doses of drugs are tested initiallyb) Cohorts with the lowest doses are evaluated before dose is escalated gradually in later cohorts.c) Subjects are frequently located in an observation center to monitor serious adverse eventsd) All of the above d) All of the above a) The lowest doses of drugs are tested initially
a) Treatment drugs are discontinued prior to study drugs for a period of time A washout in clinical trial denotesa) Treatment drugs are discontinued prior to study drugs for a period of timeb) Special hygiene measures are used in the clinical trialc) Physician consultation is used prior to administration of study drugd) All of the above
b) Have an SOP for monitoring the subjects during the washout period In a clinical trial of schizophrenia the study design calls for a washout of the current treatment drug prior to administration of the study drug. The sponsor shoulda) Inform the subject’s physician prior to administration of the study drugb) Have an SOP for monitoring the subjects during the washout periodc) Allow a subject to self-administer any drug during the washout periodd) Make the washout period as short as possible regardless of the drug’s half-life.
d) 1000 fold The drug concentration used in preclinical studies is likely to higher than in human studies bya) 5 foldb) 10 foldc) 100foldd) 1000 fold
c) Patients with cancer who have failed standard therapy In a phase 1 oncology study in adults the subjects are likely to bea) Healthy volunteersb) Patients in remissionc) Patients with cancer who have failed standard therapyd) Patients who are terminally ill.
d) Therapeutic misconception Patients who enroll in clinical trials on the assumption that they will be cured are subject toa) Self-deceptionb) Misinterpretationc) Optimismd) Therapeutic misconception
c) Parallel design In a phase 3 trial subjects are randomized to a treatment group and a control (drug) group. The assignments remain unchanged for the duration of the trial. This is an example of what study designa) Pre-post designb) Crossover designc) Parallel designd) Matched pair design
b) Pre post design In a phase 2 design of hypertensive drugs the following protocols implemented. The patient’s blood pressure is taken and the blood pressure is measured. The treatment drug is then given and the blood pressure is measured again. This is an example ofa) Factorial designb) Pre post designc) Parallel designd) Crossover design
c) Crossover design In a phase 3 trial the following treatment scheme is adopted. Group A patients are started on the treatment drug and after a period of time switched over to the control drug. Group B patients are started on the control drug and then switched over to the treatment drug. This study design is an example ofa) Parallel designb) Factorial designc) Crossover designd) Matched pair design
b) Factorial design In a phase 3 trial four treatment groups are identified Placebo X and active group X, Placebo Y and active group Y. The subjects are randomized to all four groups. The study design is an example ofa) Parallel designb) Factorial designc) Crossover designd) Withdrawal trial design
c) Treatment drug with a comparator control The Declaration of Helsinki advises this design for clinical trials whenever possible:a) Double blinded placebo controlb) Single blinded placebo controlc) Treatment drug with a comparator controld) Open label treatment
a) A superiority trial with the best performing drug as comparator control “A drug manufacturer has developed a new drug for hypertension. There are currently 15 drugs available for the treatment of hypertension. The trial design that would be most favored would bea) A superiority trial with the best performing drug as comparator controlb) A non-inferiorly trial with an “”average”” performing drug as comparator controlc) An equivalence trial with an “”average”” performing drug as a controld) A placebo control trial with high statistical power.”
c) Withdrawal trial In a clinical trial the following design is followed. All subjects are placed on the treatment drug for a period of time. The baseline measure is then taken. Then they are randomized into two groups. One group receives the treatment drug and the other group receives a placebo. The patients are then reevaluated for the outcome measure. This design is an example ofa) Crossover designb) Parallel designc) Withdrawal triald) Factorial design
Bias in a clinical trial can result froma) Aspects of trial designb) Operational aspects of the trialc) Statistical analysis and evaluation of the resultsd) All of the above d) All of the above a) Aspects of trial design
d) Randomization and blinding The most common techniques utilized to prevent bias in a clinical trial area) Small sample sizes and frequent measurementsb) Large sample sizes but low statistical powerc) Large sample sizes and high p valuesd) Randomization and blinding
b) Double blinding In a two group parallel design trial neither the investigator nor the subject is aware of whether the group is the treatment drug or a placebo. This is an example ofa) Single blindingb) Double blindingc) Open labeld) None of the above
b) Both the investigator and the subject know that the treatment drug is being administered. In an open label triala) The investigator knows whether the treatment is placebo or treatmentb) Both the investigator and the subject know that the treatment drug is being administeredc) Neither the investigator not the subject knows whether drug or placebo is being administeredd) The investigator knows that the drug is being administered but the subject does not
c) The investigator knows that the drug is being administered but the subject does not In a single blind triala) Both the investigator and the subject know that the treatment drug is being administered.b) Neither the investigator nor the subject knows whether drug or placebo is being administeredc) The investigator knows that the drug is being administered but the subject does notd) The subject knows that the drug is being administered but the investigator does not
A placebo control design is justified whena) High placebo response is expectedb) Treatment drug is anticipated to have fluctuating outcomesc) There is mixed data on the effectiveness of the current standard treatmentd) All of the above d) All of the above a) High placebo response is expected
A placebo design in a clinical trial is contraindicated whena) Placebo may cause serious harm to the subjectb) When a good comparator drug exists for the trialc) Where a high rate of morbidity exists for the patients with the diseased) All of the above d) All of the above a) Placebo may cause serious harm to the subject
Disadvantages of a crossover design includea) A carryover effect from one treatment to the otherb) Often not possible for acute diseasec) Cannot be used when the initial treatment has long term or permanent effect (e.g. vaccine trials)d) All of the above d) All of the above a) A carryover effect from one treatment to the other
In a matched pair designa) For every subject assigned to treatment group A a matched subject on given characteristics is assigned to treatment group Bb) Intergroup variability is reduced thus lowering the influence of confounding factorsc) May be difficult to implement relative to unmatched parallel group designd) All of the above
In a double blinded placebo control design the reasons for the blinding of the investigator includea) Prevent the investigator from reviewing the treatment group more strenuouslyb) Prevent the investigator from not recording or reporting serious adverse events in the treatment groupc) Prevent the investigator from making protocol changes which favor the treatment groupd) All of the above d) All of the above a) Prevent the investigator from reviewing the treatment group more strenuously
Blinding is not advised in the evaluation of a significant risk device in a clinical trial becausea) Installation of sham device would be unacceptable.b) The choice between surgery and no surgery for the two groups may mask the real risks of the device to the subjectc) Both a and bd) Neither a nor b c) Both a and b a) Installation of sham device would be unacceptable.
b) In phase one bioequivalence trials Crossover studies are particularly favored ina) Where the placebo group shows large variationsb) In phase one bioequivalence trialsc) Where long acting drugs are involvedd) When a short treatment time is desired for the clinical trial.
a) Phase 1 trials Dose escalation is most likely to be used ina) Phase 1 trialsb) Phase 2 trialsc) Phase 3 trialsd) Phase 4 trials
The goals of a phase 4 trial includea) Detection of rare side effectsb) Detection of side effects associated with chronic use of the drugc) Desensitization and loss of effect of the drug upon continued treatmentd) All of the above d) All of the above a) Detection of rare side effects
) The sponsor reports it to the FDA which then imposes a black box warning on the product label An important rare side effect is observed for a drug in phase 4 trial. The likely outcome would bea) The sponsor ignores the effect because it is rareb) The sponsor decides not to report it to the FDAc) The sponsor reports it to the FDA which then imposes a black box warning on the product labeld) The sponsor reports it to the FDA which resolves not to act on the information
The advantages of a disease registry over a specific drug registry in a phase 4 trial isa) It provides insights into comparative side effectsb) It provides assessments of cost effectiveness of the different drugsc) It may allow for comparative assessments of efficacy in the long rund) All of the above d) All of the above a) It provides insights into comparative side effects
c) Phase 3 The trial which would most influence FDA approval and the final product label for a drug isa) Phase 1b) Phase 2c) Phase 3d) Phase 4
d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial The placebo effect in experimental studies isa) An effect caused in a treatment group because of the special attention paid to it by the investigatorb) The participants form an interpretation of the experiment’s purpose and modify their behavior accordinglyc) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical triale) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.Patientsinthecontrolgroupbecomeawareofgroupmembershipandturnrebellious and alter behavior to contradict the experiment’s purpose
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly An example of demand characteristics in an experimental study isa) An effect caused in a treatment group because of the special attention paid to it by the investigatorb) The participants form an interpretation of the experiment’s purpose and modify their behavior accordinglyc) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical triale) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose
c) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait An example of a halo effect in a psychosocial study isa) An effect caused in a treatment group because of the special attention paid to it by the investigatorb) The participants form an interpretation of the experiment’s purpose and modify their behavior accordinglyc) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another traitd) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical triale) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose
a) An effect caused in a treatment group because of the special attention paid to it by the investigator The Hawthorne effect isa) An effect caused in a treatment group because of the special attention paid to it by the investigatorb) The participants form an interpretation of the experiment’s purpose and modify their behavior accordinglyc) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical triale) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.f) Patients in the control group become aware of group membership and tum rebellious and alter behavior to contradict the experiment’s purpose
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results Investigator bias in an experimental study isa) An effect caused in a treatment group because of the special attention paid to it by the investigatorb) The participants form an interpretation of the experiment’s purpose and modify their behavior accordinglyc) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical triale) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the resultsf) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose The John Henry effect in an experimental study isa) An effect caused in a treatment group because of the special attention paid to it by the investigatorb) The participants form an interpretation of the experiment’s purpose and modify their behavior accordinglyc) Occurs in cognitive trials where the perception of one trait is influenced by the perception of another traitd) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical triale) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose
a) Protocol, consent forms, recruiting scripts, investigator’s brochure According to the FDA guidance on recruitment for studies under an IND, the following information needs to be reviewed by the IRB:a) Protocol, consent forms, recruiting scripts, investigator’s brochureb) Protocol, debriefing forms, conflict of interest information, recruitment scriptsc) Protocol, research monitoring plans, recruitment scripts, consent formsd) Protocol, enrollment bonuses, consent forms and investigator’s brochure
According to the FDA guidance on recruitment the following do not need IRB reviewa) Communications intended to be seen or heard by health professionalsb) New storiesc) Publicity such as financial page advertisements intended for investorsd) All of the above d) All of the above a) Communications intended to be seen or heard by health professionals
a) It lists title, protocol summary, basic eligibility criteria, location and contact information According to the FDA guidance on recruitment a web listing of a clinical trial does not need IRB review ifa) It lists title, protocol summary, basic eligibility criteria, location and contact informationb) It discusses benefits in detailc) It provides payment incentive informationd) It provides a list of free medical services beyond that in the consent document
d) Dear doctor letters even when soliciting for study subjects According to the FDA guidance on recruitment which of the following does not need IRB reviewa) Brochures to be confined to the clinic waiting roomb) Flyers posted only in the institutionc) E-mails sent to potential community participantsd) Dear doctor letters even when soliciting for study subjects
d) Must be declared in the consent form A listing of a clinical trial on clincaltrials.gov a) ls regarded by the IRB as a recruitment toolb) Must be approved by the institutionc) Can be approved by the expedited processd) Must be declared in the consent form
c) Institution B is not engaged in the research Investigator in institution A is carrying out an IRB approved studies and wishes to post flyers for his study in Institution B. According to OHRP guidancea) Institution B must carry out an IRB review of the study.b) Only the institution B’s institutional official needs to be notifiedc) Institution B is not engaged in the researchd) Institution B needs to have an FWA
IRB concerns about recruitment activities may includea) Completeness of information provided.b) Subtle coercion of the subjects in advertisementsc) Compromised confidentiality in the initial recruitment process.d) All of the above d) All of the above a) Completeness of information provided.
c) Be free of coercion and undue influence According to federal regulations, recruitment related activities for a clinical triala) Should be free of biasb) Should provide payment related incentivesc) Be free of coercion and undue influenced) Imply the possibility of a cure
d) All of the investigator’s recruitment materials In a sponsored clinical trial the IRB should reviewa) The sponsor’s recruitment effortsb) Differences between the principal investigator’s recruitment efforts and the sponsor’s.c) Only a summary of the media advertisements being used by the Pld) All of the investigator’s recruitment materials
c) Leave the clinical trial brochures in his waiting room and provide his research staff member as the contact for further information A physician wishes to inform his patients about a clinical trial for which he is the principal investigator.He shoulda) Present the information in person to the patientb) Ask his nursing staff to present information to the patientsc) Leave the clinical trial brochures in his waiting room and provide his research staff member as the contact for further informationd) E-mail the information to his patients with a recommendation for enrollment thus avoiding direct patient contact
Enrollment bonuses paid to investigators in a clinical trial representa) Undue influence in the recruitment processb) Are not addressed in DHHS regulationsc) Reflect the sponsor’s pressure to increase enrollmentd) All of the above d) All of the above a) Undue influence in the recruitment process
d) Should be reported to the IRB and the Conflict of Interest Committee in the initial IRB application Enrollment bonuses paid to investigators by sponsorsa) Are regulated by the FDAb) Are described in DHHS regulationsc) Should be declared to the IRB by the sponsors of the clinical triald) Should be reported to the IRB and the Conflict of Interest Committee in the initial IRB application
Non-monetary reward for recruitment offered to investigators by sponsors may includea) Token giftsb) Promise of authorship of the clinical trial findingsc) Post study rewards including speakership bureau assignmentsd) All of the above d) All of the above a) Token gifts
a) Time and inconvenience Payments to research subjects should be based ona) Time and inconvenienceb) Risk and discomfortc) Ensuring participationd) Satisfying the needs of study participants
d) Should be given as gift certificates only According to FDA guidance the payments to research subjects should bea) An upfront paymentb) A lump sum given at the end of the studyc) Should be prorated in accordance with the research related visits d) Should be given as gift certificates only
c) The payment may constitute undue influence In a questionnaire study of homeless subjects the investigator wishes to pay each subject$10. The IRB could be concerned about this payment becausea) The payment could be used to pay for drugsb) The payment violates the principle of justice in the Belmont report because non study participants are not being paidc) The payment may constitute undue influenced) The payment may be too small in consideration of the principle of beneficence in the Belmont report
b) The principle of justice In assessing the payments to subjects in light of the Belmont report the IRB should be concerned abouta) Respect for personsb) The principle of justicec) The principle of beneficenced) Loss of dignity
d) Permitted under the guidance According to FDA guidance the payment of a completion bonus for a clinical trial isa) Undue influenceb) Constitutes coercionc) Violates the principle of justice in the Belmont reportd) Permitted under the guidance
b) It is not uncommon for subjects to be paid for their participation in research According to the FDA guidance on payments which of the following appliesa) May be viewed as a recruitment incentive or a benefitb) It is not uncommon for subjects to be paid for their participation in researchc) May be considered as coerciond) Is higher in phase 1 studies
d) Is not addressed in the DHHS regulations Payments to children for research participationa) Is prohibited under DHHS regulationsb) Should be given only to the parentc) Must be in the form of a gift certificated) Is not addressed in the DHHS regulations
c) Reimbursement model to cover a subject’s reasonable expenses Among the various models proposed for payments to research subjects the IRB is most likely to favora) The Market model which suggests that payments be regulated by the laws of supply and demandb) A wage payment model in which payment would be based on reimbursement for wages for time involved but close to the minimum wage.c) Reimbursement model to cover a subject’s reasonable expensesd) A benefit model which views the payment as a supplemented benefit
c) Payments should be made up to and including the latest visit When a subject voluntarily withdraws from participation in a research study:a) Payments for past visits should be withheldb) The rate of payment should be recalculated based on the completed visitsc) Payments should be made up to and including the latest visitd) Payments should be made for all visits regardless
b) Undue influence; coercion Payment in a lump sum at the beginning of the research study may be viewed as——— ;while payment in a lump sum at the end of the visit schedule may constitute —a) Convenient; a late paymentb) Undue influence; coercionc) Beneficence; disrespect for personsd) Justice; maleficence
b) Should be disclosed in detail in the consent form According to FDA guidance information on payments to subjectsa) Need not be disclosed to the subjects until the first visitb) Should be disclosed in detail in the consent formc) May be verbally communicated to the subjectd) May be disclosed in general terms in the consent form without committing to a dollar amount
Withdrawal of subjects from a research study implies thata) Activities involving interaction or intervention must ceaseb) Accessing identifiable private information about the subject be discontinuedc) Observation or recording of private behavior must be stoppedd) All of the above d) All of the above a) Activities involving interaction or intervention must cease
A subject withdrawing from a primary intervention component may still opt to continue secondary interventions which can includea) Activities that involve interventions other than those of the primary student interaction, including radiography and venipunctureb) Accessing private information including medical, educational or social service agency recordsc) Participation in studies required to monitor the long term safety of the subject.d) All of the above
d) Ask the subject if participation in secondary interventional components should continue If an investigator terminates a subject’s participation in a clinical trial, according to OHRP guidance the investigator shoulda) Terminate all study activities and make sure that no involvement with the subject is ongoingb) Include activities which are non-interventional onlyc) Consult with their private physician about activities which might continued) Ask the subject if participation in secondary interventional components should continue
d) Choose to honor the request after consultation with NIH, FDA and the appropriate regulatory agency A subject who has withdrawn from a research study requests that all of their data be destroyed. According to OHRP guidance the investigator shoulda) Destroy the data immediatelyb) Refuse categorically to destroy the datac) Refer the matter to the IRBd) Choose to honor the request after consultation with NIH, FDA and the appropriate regulatory agency
When a subject withdraws from the research study, the investigator should according to OHRP guidance:a) Document whether the withdrawal was a decision of the subject or the investigatorb) Document whether the withdrawal applied to both the primary and secondary components of the researchc) Report the matter to the IRB depending on the prevailing institutional policyd) All of the above d) All of the above a) Document whether the withdrawal was a decision of the subject or the investigator
d) All data collected up to the time of withdrawal must remain in the trial data base in order for the study to be scientifically valid According to the FDA when a subject withdraws from a clinical trial:a) All data should be destroyed related to that individualb) Only data related to serious adverse events be retainedc) The data be kept only if the IRB recommends itd) All data collected up to the time of withdrawal must remain in the trial data base in order for the study to be scientifically valid
b) FDA regulations, but not in DHHS regulations The ability of the investigator to retain and analyze the data of a withdrawn subject even if the data includes identifiable information is permitted ina) DHHS regulations, but not the FDA regulationsb) FDA regulations, but not in DHHS regulationsc) Neither FDA nor DHHS regulationsd) Both FDA and DHHS regulations
According to HIPAA if the research subject revokes a HIPAA authorization:a) The revocation has to be in writingb) The revocation does not affect the use or disclosure of data prior to the revocationc) Both a and bd) Neither a nor b c) Both a and b a) The revocation has to be in writing
b) Must be explained with regard to data retention in light of the prevailing FDA, DHHS and HIPAA regulations “According to OHRP guidance the informed consent element that the subject may “”discontinue participation at any time””a) Can be stated without any reservationsb) Must be explained with regard to data retention in light of the prevailing FDA, DHHS and HIPAA regulationsc) Will be honored by destroying all datad) Can be overruled by the investigator even if the subject requests it”
c) $400 The costs of a clinical trial are apportioned so that the following procedure will be reimbursed1. One MRI at $1002. Lab tests for the initial visit $503. One ECG at $50A patient undergoing three visits each with an MRI a lab tests and an ECG would-be liable for a) $200b) $300c) $400d) $500
c) Ask for updates on the Pl’s conflict of interest During a monitoring visit the monitor would do all of the following excepta) Review discrepancies in CRFs and source documents with the Pl or CRCb) Review informed consent forms signed by new enrolleesc) Ask for updates on the Pl’s conflict of interestd) Update the regulatory document binder
c) Assume that the subject has read and understood the form For a subject who has had a consent form emailed to him the CRC should ensure all excepta) The subject brings the consent form to the conferenceb) Supply a new consent form if the subject has forgotten to bring the consent form with himc) Assume that the subject has read and understood the formd) Have the subject sign and date the form while the CRC is present
c) 30 1.1 A monitor assessing drug accountability makes a note of the following• The sponsor has mailed 50 vials to the site research pharmacist• Thirty vials were dispensed to patients• Of the ones dispensed 20 were usedThe number of vials eligible for drug destruction isa) 10b) 20c) 30d) 40
c) 75kg The subject’s weight in his medical record is reported at 150 lbs. What would be his approximate weight in kg?a) 175 kgb) 100kgc) 75kgd) 35 kg
b) The PI A subject on a test drug for allergic rhinitis reports to the CRC that he was hospitalized for respiratory distress because the test drug is not working. The CRC should immediately informa) The sponsorb) The PIc) The IRBd) The regulatory agency
a) The sponsor A subject on a test drug experiences a hospitalization while on the drug for a period of four weeks at a hospital other than the site’s hospital. The CRC learns of it though a family member. The CRC should report it immediately toa) The sponsorb) The IRBc) The regulatory agencyd) The relevant family members
a) Not be enrolled in the clinical trial at the time of presentation The inclusion criterion for a clinical trial sates that the subject should not have a liver or renal function test outside the normal range. His values are1. AST 20 2. ALT 103. Serum creatinine 2.0 The subject shoulda) Not be enrolled in the clinical trial at the time of presentationb) Be enrolled in a clinical trialc) Should be evaluated in another month to see if the lab values were stabled) Should be evaluated clinically by the Pl
In order to increase the enrollment number of sites in a clinical trial was doubled. The Pl when notified shoulda) Share the information with the research teamb) File and amendment with the IRBc) Update the consent form and ask the sponsor, if reconsent of enrolled subjects is requiredd) band C d) b and c b) File and amendment with the IRB
A sponsor investigator of a clinical trial increases the number of sites to enhance enrollment . The sponsor investigator shoulda) Inform the IRBb) Arrange for monitoring of the added sitesc) Arrange for the new sites to be updated on any new findings and IND safety reportsd) All of the above d) All of the above a) Inform the IRB
b) 15 In screening for eligibility for a clinical trial 50 medical records were screened. Of these, 50% were screened failures. Of the remaining 10 failed the lab tests at visit 0. The number who proceeded to be evaluable isa) 30b) 15c) 10d) 5
d) Measures using tape of swelling size in key joints A patient in a rheumatoid arthritis clinical trial is required to keep a pain and symptom diary. Which of the following measures would be considered objective in evaluating the trial’s efficacy variablea) Number of sleepless nights due to joint painb) Ability to go for a runc) Number of days off workd) Measures using tape of swelling size in key joints
d) Review the Pl’s previous list of treated subjects to assess if enrollment targets will be met A CRC wishes to be ready for potential enrollment into a clinical trial. The study application is still under review with the IRB. In this situation the most that he can do isa) Call potential subjects and discuss enrollmentb) Review the proposed informed consent form with potential subjectsc) Review the medical records of potential subjects for eligibilityd) Review the Pl’s previous list of treated subjects to assess if enrollment targets will be met
c) The schedule of assessments A CRC is preparing a project tracker for following the progress of enrolled subjects in a clinical trial for study initiation to study close out. He should followa) The protocolb) The enrollment logc) The schedule of assessments d) The screening log
c) Unexpected and serious and should be reported to the IRB A subject in a clinical trial experiences severe diarrhea, which requires hospitalization an event not described in the investigator’s brochure. The event isa) Not serious because it is not life threateningb) Expected by the Pl and not reportable to the IRBc) Unexpected and serious and should be reported to the IRBd) Should be reported as an adverse event to the sponsor, but not the IRB
b) Inform the sponsor prior to rescheduling the visit A subject in a clinical trial is late for a critical visit scheduled for the study. The CRC shoulda) Reschedule the visit immediatelyb) Inform the sponsor prior to rescheduling the visitc) Inform the IRBd) Immediately report the event as an SAE
c) 1.4 The serum creatinine values for a subject on three consecutive visits are 1.6, 1.4, and1.2. the mean value which can be used to determine if the subject should proceed in the clinical trial isa) 1.1b) 1.3c) 1.4d) 1.5
A subject being screened for a clinical trial of a drug for allergic rhinitis presents with a heart rate of 110 beats per minute. Tachycardia is not an exclusion criterion for the study. The CRC shoulda) Ask the sponsor’s medical safety officer if the subject should be enrolledb) Do a repeat measurement of heart rate, in two weeks or more, to see if the symptom is repeatablec) Ask the subject if he has experienced any symptoms of a rapid heart beatd) All of the above d) All of the above a) Ask the sponsor’s medical safety officer if the subject should be enrolled
In doing a note to the informed consent the CRC should recorda) If an interpreter was present and information about the interpreterb) The date, time ,place and duration of the consent processc) The use of a witness or legal guardiand) The fact that all queries were answered and no procedures initiated prior to the conferencee) All of the above e) All of the above a) If an interpreter was present and information about the interpreter
The sponsor changes the eligibility criteria for an IRB approved protocol and adds a QOL questionnaire . The Pl should submit the following to the IRBa) An amendment applicationb) The modified protocolc) The altered investigator’s brochure that triggered the changed) A revised consent forme) All of the above e) All of the above a) An amendment application
During the course of a clinical trial the CRC notices that the HCT values have been consistently low in several subjects. Upon further investigation it was discovered that the lab assistant was storing the samples under his desk and sending the entire batch for analysis once every week. The CRC shouldg) Immediately inform the Plh) File a protocol deviation with the IRBi) Inform the sponsorj) Arrange to have the lab assistant retrained or disciplinedk) Initiate a CAPA planI) All of the above I) All of the above g) Immediately inform the Pl
In a clinical trial for an oral anti-inflammatory drug the CRC notices that the patients have consistently misunderstood the instructions to take the drug. The CRC shoulda) Investigate who has been doing the informed consent conferencesb) Arrange to retrain the individuals administering consentc) Reconsent the subjectsd) All of the above d) All of the above a) Investigate who has been doing the informed consent conferences
a) Obtaining information about demographics, medical history and lab tests for the subject The requirements for a screening consent would be indicated for all of the following excepta) Obtaining information about demographics, medical history and lab tests for the subjectb) Conducting a CT scan prior to progression in the clinical trialc) Initiating a washout of current drug treatmentsd) Administering a diagnostic drug for a thyroid condition
c) 50% A subject has to take his medication twice a day and is given a pill box with a counter to assess compliance for the week. The pill count at the end of the week shows one tablet left on Monday, Tuesday, Wednesday, Thursday and Friday and two pills left on Saturday. The compliance rate isa) 20%b) 40%c) 50%d) 80%
d) File an unanticipated event report with the IRB A CRC has scheduled a first visit for a subject for an IRB approved study. When the patient arrives the CRC notices that the IRB approval letter is missing a date. The CRC should do all of the following excepta) Reschedule the visitb) Contact the IRB and ask for a dated letterc) Inform the Pld) File an unanticipated event report with the IRB
h) Children with lymphoma who have failed standard treatment A phase I oncology study for lymphoma in children should enrolle) Healthy adultsf) Healthy childreng) Children with any known cancerh) Children with lymphoma who have failed standard treatment
Which of the following statements regarding informed consent are true?a) The consent form should have a signature and date of the subject and the person obtaining consentb) The source documents or note to the informed consent should document that consent was obtained prior to the trial related proceduresc) Where the informed consent is administered in an emergency setting both the date as well as the time of the consent relative to the first trial related procedure should be documentedd) All of the above
The monitoring of blood pressure prior to taking the drug is required in a clinical trial. The CRC notices that the blood pressure readings have been recording abnormally low blood pressures and suspects the blood pressure monitors may not be adequate. The CRC shoulda) Notify the sponsorb) First notify the Plc) Notify the IRB by filing a protocol deviationd) All of the above d) All of the above a) Notify the sponsor
d) Reschedule the meeting The sponsor’s SOP requires the Pl to be present for a site initiation visit but scheduling prevents the Pl form being present for the date set by the sponsor. The CRC shoulda) Sign for the Plb) Proceed with the site initiation visitc) Schedule the meeting and subsequently train the Pl himselfd) Reschedule the meeting
c) Ask the subject to take the consent form with him and bring it back for another scheduled consent conference During the informed consent process the Pl receives an emergency call from a patient and has to curtail the conference. The CRC shoulda) Ask the subject to sign the consent as most of the conference was conductedb) Take over the conference himself and complete itc) Ask the subject to take the consent form with him and bring it back for another scheduled consent conferenced) Report the incident as a protocol deviation to the IRB
During a clinical trial the Pl has to leave the country to take care of a relative abroad. The CRC shoulda) Make sure either the co-investigator or sub investigator takes over for the Pl per written instructions from the Plb) Update the delegation log to reflect the new situationc) File and amendment with the IRB indicating a temporary change of personneld) All of the above d) All of the above a) Make sure either the co-investigator or sub investigator takes over for the Pl per written instructions from the Pl
A subject being consented for a clinical trial is blind. The CRC shoulda) Obtain a Braille version of the consent formb) A legally acceptable guardian help the subject sign and the LAR should sign the consent form as wellc) Have the complete consent form read to the subjectd) All of the above d) All of the above a) Obtain a Braille version of the consent form
d) Serum creatinine Which of the following is a renal function test?a) ASTb) ALTc) ALPd) Serum creatinine
a) AST Which of the following is a liver function test?a) ASTb) BUNc) Serum Creatinined) GFR
a) Erythrocyte Sedimentation Rate Which of the following is simple test for rheumatoid arthritis or joint disease?a) Erythrocyte Sedimentation Rateb) ASTc) Serum creatinined) Urine microalbumin
a) HbA1c Which of the following is a test for Type II diabetes?a) HbA1cb) ALTc) BUNd) Anti-nuclear antigen
a) Do you understand juvenile arthritis symptoms and causes A child seven years old is being consented for a juvenile arthritis clinical trial for a new oral medication. The question that would be important to ask the child would include all of the following excepta) Do you understand juvenile arthritis symptoms and causesb) Do you have difficulty swallowingc) What oral medications have you take befored) Do you prefer to have a liquid formulation
d) Tell the subject that it is not serious A subject in a clinical trial who has been through two earlier visits develops hives and calls the CRC. The CRC should do all of the following excepta) Schedule the subject for an additional visitb) First notify the Plc) Ask the Pl if an SAE report to the IRB is indicated d) Tell the subject that it is not serious
A drug with a half-life of 1 day is initiated at 100mg dose. How much drug would be left in the subject’s blood stream after four days?a) 50 mgb) 75 mgc) 35 mgd) 12.5 mg d) 12.5 mg 1 day=100mg
b) 25 mg1 day=100mg2 day=50mg3 day=25mg4 day=12.5 A drug with a half-life of one day is initiated at 100mg. The subject does not take the drug for three days. The minimum effective concentration is 50 mg. The maintenance dose that should be administered isa) 50 mgb) 25 mgc) 75 mgd) 12.5mg
d) All of the abovea) First indicate to the Pl that the inclusion criterion has not been metb) Permit the Pl to request a medical waiver of eligibility for the subjectc) Not consent the subject until the sponsor has approved the medical waiver The inclusion criteria for a clinical trial indicate that the serum creatinine should not exceed 1.2 mg. A subject repents with a serum creatinine of 1.25 and meets all the other inclusion criteria. The Pl feels that the subject is appropriate for the trial. The CRC shoulda) First indicate to the Pl that the inclusion criterion has not been metb) Permit the Pl to request a medical waiver of eligibility for the subjectc) Not consent the subject until the sponsor has approved the medical waiverd) All of the above
The appropriate documents to send to the sponsor for a study close out visit includea) Drug accountability recordsb) Remaining data clarification formsc) The key to the coded samplesd) All of the above d) All of the above a) Drug accountability records
c) That participation is voluntary, without penalty or loss of benefits An essential element of informed consent affirmed in most ethical frameworks isa) That the research should bear fruitful resultsb) That the risk of the research should always be minimalc) That participation is voluntary, without penalty or loss of benefitsd) That compensation for research is fair
c) The subject may discontinue participation at any time without penalty An essential element of consent that is affirmed in most ethical frameworks is thata) There should be compensation for medical injuryb) There should be no deception used in the studyc) The subject may discontinue participation at any time without penaltyd) Drugs which might diminish the quality of life not be used.
The essential basic elements of consent includea) A statement that the study involves research and its purposeb) A description and identification of experimental proceduresc) The duration of the studyd) All of the above d) All of the above a) A statement that the study involves research and its purpose
The essential basic elements of consent includea) Statements about the risk, benefits and alternate proceduresb) Any compensation for injuryc) Confidentiality of records and contact information regarding subject’s rightsd) All of the above d) All of the above a) Statements about the risk, benefits and alternate procedures
d) Is an added element included on the consent form only if the IRB deems itappropriate to do so
b) Include the need for contraception Regarding the risks of pregnancy and harm to the fetus during the research study, the consent form requires that ita) Mention the procedure may involve such risks that are unforeseeableb) Include the need for contraceptionc) Provide specific instructions regarding the efficacy of specific contraceptive methodsd) Advise subjects that only women need to be aware of such risks
Regarding the termination or withdrawal of a subject from a research study the consent form shoulda) Advise that termination may occur without the subject’s consentb) Advise regarding the consequences of the subject’s decision to withdrawc) Describe the circumstances in which such termination might occurd) Provide procedures for orderly terminatione) All of the above e) All of the above a) Advise that termination may occur without the subject’s consent
b) Disclose any additional costs as this is an additional element of consent Regarding costs of the research to the subject the consent form shoulda) Assume the subject knows that the institution will pay for all research costsb) Disclose any additional costs as this is an additional element of consentc) Provide detailed analysis of the study’s cost structured) Transfer as much of the costs to the subject as possible
c) Provide the subject with an idea of how risks and burdens are being shared An additional element of consent to be disclosed to subjects in the consent form if appropriate, is the number of subjects involved in the study. The likely reason behind this requirement isa) Satisfy the subject’s curiosityb) The sponsor’s desire to impress the subject with the enrollment numbersc) Provide the subject with an idea of how risks and burdens are being sharedd) Assure subjects that they are not alone in their decision to enroll
d) Explain the probability for random assignment to each treatment group In ICH a clinical trial with randomization shoulda) Explain the reasons for the use of control groupsb) Provide a justification for why an active control group is or is not being usedc) Should describe the need for placebo controlled designd) Explain the probability for random assignment to each treatment group
c) The subject In ICH the consent form should explain the responsibilities ofa) The sponsorb) The investigatorc) The subjectd) The IRB and other regulatory agencies
In describing the risks of a clinical trial the informed consent should detail the risks toa) The subjectb) Embryo or fetusc) Nursing infantd) All of the above d) All of the above a) The subject
In a clinical trial regarding the statement of benefitsa) Reasonably foreseeable benefits should be statedb) Explicitly indicate that there are no benefits if none are expectedc) a onlyd) a and b d) a and b a) Reasonably foreseeable benefits should be stated
d) Merely state if compensation is available Regarding compensation for trial-related injury the informed consent shoulda) Provide no fault insuranceb) Always state that no compensation will be providedc) State that medical care but no compensation is available d) Merely state if compensation is available
d) The anticipated prorated payment will be stated Regarding payments in the informed consent ICH implies thata) A statement that fair payment is being made should be includedb) The payment will be based on the risk and discomfort of the clinical trialc) The payment will be based on time and inconvenienced) The anticipated prorated payment will be stated
d) State the anticipated expenses, if any Regarding the subjects’s expenses the informed consent should statea) That every effort to cover all expenses will be madeb) Detail the expenses which will or will not be coveredc) Make no commitment regarding expensesd) State the anticipated expenses, if any
d) The access to the medical record should be limited to protect the confidentiality of the subject and permitted by applicable laws and regulations Regarding access to the subject’s medical records the informed consent should statea) That the original medical record will be abstracted but not directly accessed for cellular trial datab) The monitor will always have access to the medical recordc) That signing of the informed consent automatically authorizes public release of the medical recordd) The access to the medical record should be limited to protect the confidentiality of the subject and permitted by applicable laws and regulations
d) Information relevant to the continued participation of the subject in the clinical trial The informed consent defines significant new information that should be updated in the informed consent as includinga) Other new clinical trials on the same drugb) Other new drugs that have come on the marketc) New side effects of the most commonly used alternative medicationd) Information relevant to the continued participation of the subject in the clinical trial
d) The person or persons to contact Regarding contact information about the rights of a trial subject the informed consent should mentiona) The institutionb) The investigatorc) The IRBd) The person or persons to contact
b) The investigator or other designated person for medical safety The most likely person to contact for a trial related injury would bea) The IRBb) The investigator or other designated person for medical safetyc) The sponsord) The institution
For a patient with dementia the informed consent process should ensure thata) Consent of the legally acceptable representative should be obtainedb) The subject should be informed about the trial to the extent compatible with understandingc) If capable the subject should sign and personally date the written informed consentd) All of the above d) All of the above a) Consent of the legally acceptable representative should be obtained
The informed consent should be signed bya) The subjectb) The legally acceptable representative if applicablec) The person conducting the consent discussiond) All of the above d) All of the above a) The subject
d) At the high school level The language of the informed consent should be all of the following excepta) Non technicalb) Practicalc) Understandable to legally acceptable representatived) At the high school level
The informed consent should adhere toa) GCPb) Declaration of Helsinkic) a onlyd) a and b d) a and b a) GCP
ICH Guideline on Good Clinical Practice (ICH E6). What ICH Guideline on Good Clinical Practice is this?The principles and practices concerning protection of trial subjects in which are stated. These principles have their origins in The Declaration of Helsinki and should be observed in the conduct of all human drug investigations.
ICH S6 Before any clinical trial is carried out, results of non-clinical investigations or previous human studies should be sufficient to indicate that the drug is acceptably safe for the proposed investigation in humans. The purpose and timing of animal pharmacology and toxicology studies intended to support studies of a given duration are discussed in ICH M3. The role of such studies for biotechnology products is cited in in which ICH Guideline and GoodClinical Practice?
The responsibilities are described in ICH E6 sponsor Institutional Review Board/Independent Ethics Committee
Human Pharmacology (Phase I Study) Study Examples • Estimate activity
Therapeutic Exploratory (Phase II Study) • Provide basis for confirmatory study design, endpoints, methodologies
Therapeutic Confirmatory (Phase III Study) • Provide an adequate basis for assessing the benefit/risk relationship to support licensing • Establish dose-response relationship
Therapeutic Use (Phase IV) • Refine dosing recommendation
9 years or more Development of most new drugs from discovery to marketing approval usually takes:
Phase II The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 subjects in each arm. Which of the following best describes the clinical phase of this study?
Phase III Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?
Pre-clinical Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
Phase I Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?
Preclinical data For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator’s Brochure?
Minimize the need for redundant research A primary purpose of the ICH is to:
Set standards for the design, conduct, monitoring and reporting of clinical research. The ICH GCP Guidelines:
Investigators, sponsors, and IRBs. The ICH E6 GCP describes standards that apply to:
Voluntary for FDA-regulated drug studies. In the United States, following the ICH E6 GCP is:
The Code of Federal Regulations. The FDA will apply:
there is a reasonable possibility that the drug caused the event The sponsor must submit an IND safety report to the FDA if an adverse event is (1) serious; (2) unexpected; AND:
Both of the subjects. A double-blinded trial for a new indication is conducted under an IND comparing 2 marketed drugs, at twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects’ medical histories. The investigator would submit an SAE report for:
Subject 603 only During the course of administration of an investigational drug, the following events occur: On Day 7, subject 603 has an unexpected stroke that requires hospitalization. On Day 15, subject 415 complains of nausea, vomiting, and headache relieved by aspirin. On Day 21, subject 20 has brief dizzy spells upon trying to stand. An IND Safety Report is most likely filed by the sponsor with the FDA for the observations associated with:
Report the elevated WBC to the sponsor as an unexpected adverse effect. “Subject 311 has had elevated white blood cell (WBC) counts for the past 2 study visits, with no clinical signs or symptoms. “”Increased WBC count”” is not listed in the Investigator’s Brochure (IB) as an adverse event. The investigator should:”
The timing of the event in relation to administration of the investigational agent When evaluating the causality of an adverse event, which of the following should be a consideration?
Ensuring subject safety. Accurate reporting of adverse events is most important for:
Report adverse events of both a broken wrist and a mild concussion. A subject is a passenger in a car involved in a motor vehicle crash. The subject sustained a broken wrist and mild concussion. The subject was treated and released from the emergency department. What should the investigator do when learning of the crash?
Principal Investigator A subject presents to the emergency department (ED) with complaints of chest pain and shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a phase I study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event?
The sponsor Identify which party is responsible for reporting directly to the FDA the investigator’s financial interests with the sponsor:
Conduct or supervise the investigation personally. In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to:
FDA Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the:
Sponsor. The investigator must report adverse events to the:
During the conduct of the study and at termination When must the investigator update the IRB about the progress of a trial?
Submit a new Form FDA 1572 to sponsor as needed Which of the following is an investigator’s commitment to the sponsor?
Drug shipping and disposition records Which of the following is an important component of drug accountability?
Investigator Who has ultimate responsibility for an investigational product?
Case report form Investigational product dispensing or administration information for the sponsor is recorded on the:
be designed to help with subject compliance The packaging of investigational drugs should ideally
In the study protocol Where is information on storage requirements for the investigational product usually found?
It is a FDA guidance What is the legal status of ICH in U.S.?
CH notes that it should be included, but does not specify how the information should be presented. In terms of explaining the probability of assignment to trial arms in consent forms, which is true?
Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject’s medical records The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following?
Termination site visit All unused investigational agents are expected to be returned to the sponsor at the:
An investigator’s agreement An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following?
Sponsor Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:
investigational agent When evaluating the causality of an adverse event, which of the following should be a consideration?The timing of the event in relation to administration of the
Report adverse events of both a broken wrist and a mild concussion. A subject of a research study is a passenger in a car involved in a motor vehicle crash. The subject sustained a broken wrist and mild concussion. The subject was treated and released from the emergency department. What should the investigator do when learning of the crash?
Principal Investigator A subject presents to the emergency department (ED) with complaints of chest pain and shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a Phase I study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event?
Report the elevated WBC to the sponsor as an unexpected adverse event “Subject 311 has had elevated white blood cell (WBC) counts for the past two (2) study visits, with no clinical signs or symptoms. “”Increased WBC count”” is not listed in the Investigator’s Brochure (IB) as an adverse event. The investigator should:”
Ensure the protection of human research subjects and data integrity The overall goal of monitoring, audits, and inspection activities is to:
Identification of protocol violations Which of the following should take place during periodic site visits?
Periodic site visits Which of the following best describes when the majority of case report form (CRF) data are verified against source record information?
Prestudy site visit Which monitoring visit would not include an inventory of investigational agents?
Be designed to help with subject compliance The packaging of investigational drugs should ideally:
When the new device to be marketed is substantially similar (equivalent) to one already on the market A 510(k) Premarket Notification is submitted:
(3) there is a reasonable possibility that the drug caused the event. The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2) unexpected; and:
Subject 603 only “During the course of administration of an investigational drug, the following events occurred: On Day 7, subject 603 had an unexpected stroke that requires hospitalization; On Day 15, subject 415 complained of nausea, vomiting, and headache relieved by aspirin; On Day 21, subject 20 has brief dizzy spells upon trying to stand. Which of these subject’s events meets the FDA definition of “”serious”” and “”unexpected”” and would require the sponsor to file an IND Safety Report with the FDA?”
A systematic and independent examination of trial-related activities and documents. “According to ICH E6, an “”audit”” is defined as:”
Review regulatory records. When the FDA conducts an inspection, the inspectors will:
Protection of human research subjects OHRP is an oversight body primarily concerned with:
An official review of documents, facilities, records, and any other resources related to a clinical trial. According to ICH E6, an inspection is defined as:
At least two (2) years after the investigational drug’s approval by the FDA The FDA requires retention of investigational drug study records for:
Site initiation visit When should the sponsor-monitor conduct the most detailed review of the study protocol with the site’s study staff?
Both of the subjects A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects’ medical histories. The investigator would submit an SAE report for:
Evaluation of the site’s capacity to conduct the study Which of the following is required at a prestudy site visit?
Adverse Drug Reaction All noxious and unintended responses to a medicinal product related to any dose should be considered an ADR.
Blinding A procedure in which one or more parties to the trial are kept unaware of the treatment assignments.
Single Blind Refers to the subject being unaware of the treatment assignment
Double Blind Refers to the subject, investigator, monitor, and sometimes analyst being unaware of the treatment.
Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
Comparator An investigational or marketed product, or a placebo, used as reference in a clinical trial.
Contract Research Organization A person or organization contracted by the sponsor to preform one or more of a sponsor’s trial-related duties and functions.
Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.
Institutional Review Board An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in the trial.
Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as reference in a clinical trial
Investigator’s Brochure A compilation of the clinical and non-clinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.
Serious Adverse Event (SAE) Any untoward medical occurrence that at any dose:-results in death,-is life-threatening,-requires inpatient hospitalization or prolongation-results in persistent or significant disability/incapacity
Source data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a trial necessary for the reconstruction and evaluation of the trial.
Sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Standard Operating Procedures (SOPs) Detailed, written instructions to achieve uniformity of the performance of a specific function.
Protect the rights and welfare of human subjects of research. The purpose of an IRB is to:
Before enrolling any patients in the study The investigator must obtain IRB approval of the study and the consent form:
Written notification saying it has been approved The IRB must inform the investigator the study has been approved by:
The full protocol and the informed consent For initial approval of proposed research, the investigator must submit to the IRB:
Must be submitted to the IRB and approved before it can be used Any proposed advertising for the study:
Increases the risks to subjects Any amendment that _ must be approved by the IRB prior to implementation
Subject is unable to give consent, no time or unable to contact next of kin, life-threatening condition, no other treatment available. Which of the following is necessary to waive consent:
False T/F: The investigator’s signature must be on the consent form?
Informed Consent The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as:
A written, signed, and dated informed consent form Informed Consent is documented by:
The subject Which signatures are required by regulation to be on the consent form?
Designing, recording, reporting, and conducting ICH E6 Guidelines provides a harmonized standard for _ clinical trials involving human subjects
Rights and well-being of study subjects and credibility of the data “What are the two main themes covered by the formal ICH definition of “”Good Clinical Practice””?”
Federal regulations, ethical codes, ICH guidelines, official guidance documents GCPs are derived from all the following:
Human subjects Non-clinical studies refer to studies that do not involve:
Phase I In which development phase might normal, healthy volunteers be given a new drug?
Phase III Large multi-center studies are usually done in which phase?
Demonstrate efficacy within the established safe dose range One of the primary purposes of a Phase II study is to:
Disposition of the study drug, case histories, care report forms, and signed ICFs By regulation, an investigator must keep records relating to:
Until the sponsor says they may be destroyed. Most sponsors will expect an investigative site to keep all study records for how long?
Only the people listed on the 1572 Financial disclosure applies to:
False T/F: Investigator meetings are a requirement for any multi-center study with six or more sites?
After the site has received all study materials and is ready to start enrollment Study initiation meetings are usually held:
Recruiting sufficient subjects One of the most difficult aspects of conducting clinical trials is:
Part of the consent process The FDA considers advertising for study subjects to be:
Be done only with prior IRB approval Payments to subjects in clinical trials should:
The subject is not compliant, Pregnancy, and the subject has intolerable medical events during treatment Potential reasons to discontinue a subject in a trial are:
The number of days around a specific date that the patient may come in for a study visit. Visit Windows
False T/F: Patient compliance with study drug dosing is a statistical issue, so site personnel do not have to be concerned about it?
The CRC Case report forms are completed by:
The CRC or the investigator In general, corrections to case report forms should be made by:
False T/F: It is a regulatory requirement to have source document for every data item collected on case report forms?
The sponsor and the IRB By regulation, investigators are required to make a final study report to:
- To ensure that the site is complying with the regulation and protocol2. There is evidence that the site is out of compliance and the sponsor wants to verify whether this is true or not. There are two main reasons why a sponsor might audit a site:
Closed In study related inspections by the FDA, the studies audited are usually:
Just starting to enroll The two main aspects of a study that will be looked at by the FDA during an inspection are:
“VAIA VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time. Despite this facility inspection classification, FDA recommends that you address any observations noted on the Form FDA 483 issued at the conclusion of the inspection or otherwise conveyed to you following the inspection. If not corrected, the same or similar conditions could lead to a future inspection being classified as “”official action indicated”” (“”OAI””).” A classification of FDA audits that says the deviations found were not serious is:
Adverse Event Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IP.
Applicable Regulatory Requirements Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
IRB Approval The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, GCP, and the applicable regulatory requirements.
Audit A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to protocol, sponsor standard operating procedures, GCP, and regulatory requirements.
Audit Report A written evaluation by the sponsor’s auditor of the results of the audit.
Audit Trail Documentation that allows reconstruction of the course of events
Trial Compliance Adherence to all trial-related requirements, GCP, and the applicable regulatory requirements.
Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.
Contract A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution or tasks and obligations and, if appropriate, on financial matters.
Direct Access Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
Essential Documents Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced
Impartial Witness A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attend the informed consent process if the subject’s or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject
Independent Ethics Committee An independent body constituted of medical professionals of non-medical members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by reviewing and approving favorable opinion on the trial protocol, the suitability of the investigator facilities, and the methods and materials to be used in obtaining and documenting ICF of subjects.
Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the site, the investigator is the responsible leader. Also called PI
Legally Acceptable Representative Any individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the trial.
Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOP, GCP, and the applicable regulatory requirements.
Nonclinical Study Biomedical studies not performed on human subjects
Protocol Amendment A written description of a change(s) to or formal clarification of a protocol
Quality Assurance All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and o requirements.
Source Document Original documents, data, records
Vulnerable Subjects Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation.Examples: patients with incurable diseases, patients in nursing homes, patients in emergency situations, refugees, minors, pregnant women.
Certified Copy A copy of the original record that has been verified (by dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure of the original.
Validation of Computerized Systems A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system.
Respect for Persons, Beneficence, Justice What are the three principles of the Belmont Report? - Do no harm2. Maximize possible benefits and minimize possible harms What are the two parts under the Principle of Beneficence?
Information, comprehension, and voluntariness The principle of informed consent as described in the Belmont Report has three parts. List these three parts.
FDA Form FDA 1572, Statement of the Investigator, is legally binding between the Investigator and the:
The sponsor Identify which party is responsible for reporting directly to the FDA the investigator’s financial interests with the sponsor?
- Conduct or supervise the investigation personally.- Report AEs to the sponsor- Retain records for two years after drug approval, disapproval, or study termination In completing Form FDA 1572, Statement of the Investigator, the investigator agrees to:
The study is minimal risk. Under which circumstance does the FDA allow verbal consent prior to participation in a research study?
The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later. An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual’s legal representative. Under the FDA regulations, what should the investigator action be?
Exculpatory language Language in the consent document through which the subject is made to waive or appear to waive any of his/her legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
9 or more years Development of most new drugs, from discovery to marketing approval, usually takes how many years?
Phase II Trial Usually enrolls a limited number of patients in a controlled study to determine a drug’s short term risks (safety) at the optimal drug dose established in a Phase 1 trial.
Phase III Trial Phase III trials usually include from several hundred to several thousand subjects determining the drug’s effectiveness.
Preclinical Long term toxicology of an experimental drug in animals most likely refers to which part of drug development?
Preclinical Data For Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator’s Brochure?
Minimize the need for redundant research The primary purpose of the ICH is to:
Set standards for the design, conduct, monitoring, and reporting of clinical research. The ICH GCP Guidelines are:
Voluntary for FDA-regulated drug studies. In the U.S, following the ICH E6 GCP is:
Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject’s medical records. ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH e6 guideline, they must.:
Identification of study risks to determine which may safely be omitted from continual monitoring. The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including what?
ICH notes that it should be included, but does not specify how the information should be presented. In terms of explaining the probability of assignment to trial arms in consent forms, what are the specification about how it must be stated?
It is a FDA guidance What is the status of ICH in the U.S?
True T/F: The FDA regulations allow subjects or the legally acceptable representatives to receive either a signed or unsigned copy of the ICF?
The study is not intended to be reported to FDA to support a new indication or support a labeling change. What is an acceptable criterion for determining that a study of an approved drug does not require an IND?
The sponsor-investigator Who is responsible for making the initial risk determination for a device being used in the study?
Drug shipping and disposition records What is an important component of drug accountability?
Designed to help with subject compliance The packaging of investigational drugs should ideally be:
An investigator’s agreement An investigator conducting a study of a medical device under an IDE is required to complete and sign a:
When the new device to be marketed is substantially similar to one already on the market When is a 510(k) Premarket Notification submitted?
The timing of the event in relation to administration of the investigational agent When evaluating causality of an adverse event, what should be a consideration?
Report AEs of the broken wrist and mild concussion. A subject of research is involved in a motor vehicle crash. The subject sustained a broken wrist and mild concussion. The subject was treated and released from the emergency department. What should be done after learning of the crash?
- serious2. unexpected3. there is a reasonable possibility that the drug caused the event The sponsor must submit an IND safety report to the FDA if an adverse event is: (3 things)
Report the elevated WBCs to the sponsor as an unexpected adverse event “Subject 311 has had elevated WBCs for the past 2 study visits, with no clinical signs or symptoms. “”Increased WBC count”” is not listed in the IB as an adverse event. The investigator should:”
An official review of documents, facilities, records, and any other resources related to a clinical trial. According to ICH E6 GCP, an inspection is defined as:
An adverse reaction occurs in patients after the study has been completed. The appropriate action on the part of the investigator include A) Report the event to the sponsor B) Consider the event for reporting as though it was a study report C) Conduct causality assessment and determination of expectedness prior to expedited reporting D) All of the above D) All of the above A) Report the event to the sponsor
B) An event where risk of death was evident at the time of the event The term, life threatening, in a serious adverse event refers to A) An event which required hospitalization B) An event where risk of death was evident at the time of the event C) An event that required treatment in an emergency room D) An event which might have caused a death if left untreated
C) By filing a complete report within 8 additional days of the initial notification Fatal or life threatening and unexpected adverse drug reactions in clinical investigations should be reported to the regulatory agencies ( check all that apply) A) No later than 7 days after first knowledge of event B) No later than 15 days after first knowledge of event C) By filing a complete report within 8 additional days of the initial notification D) By filing a complete report within 15 additional days of the initial notification
D) A and BA) Is noxious and unintended B) Occurs at normal doses used for prophylaxis For a drug that is in a Phase IV trial and adverse drug reaction is one which A) Is noxious and unintended B) Occurs at normal doses used for prophylaxis C) A only D) A and B
D) A and BA) Is an unfavorable and unintended sign, symptom or disease B) Is one that is temporary associated with drug regardless of wither it is related or not An adverse event is one which A) Is an unfavorable and unintended sign, symptom or disease B) Is one that is temporary associated with drug regardless of wither it is related or not C) A only D) A and B
D) A and BA) The other manufacturer B) Appropriate regulatory agency Adverse drug reactions in the control group should be reported to A) The other manufacturer B) Appropriate regulatory agency C) A only D) A and B
B) A causal relationship between drug and adverse event is a reasonable possibility C) The relationship of the event to drug cannot be ruled out A response to a medical product means A) A causal relationship between drug and adverse event is established B) A causal relationship between drug and adverse event is a reasonable possibility C) The relationship of the event to drug cannot be ruled out D) An event that requires active medical intervention
D) May be considered serious and should be considered for expedited reporting A patient in a clinical I trial for joint pain experiences a bronchospasm while at home The event would be A) Not reportable because it occurred in a home setting B) An adverse event which does not require reporting C) An unexpected adverse event which does not require expedited reporting D) May be considered serious and should be considered for expedited reporting
A) Root cause analysis Clinical investigation of adverse events in clinical trials requires A) Root cause analysis B) Complete medical records review C) Investigation of potential protocol deviations D) Causality assessment
D) Causality Adverse events of marketed drug usually imply A) Multi drug reactions B) Unreliable subjective measures C) Psychosomatic factors D) Causality
B) Care should be taken to break the blind only for the single patient involved In ascertaining the basis for a serious adverse drug reaction in a randomized trial A) Care should be taken not to break the blind for the patient B) Care should be taken to break the blind only for the single patient involved C) The blind for the group of patients being treated at the site should be broken D) The blind for the single patient should be broken only if the sponsor approves