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

ACRP CCRC Exam (Latest 2024/ 2025
Update) Questions and Verified Answers|
100% Correct| Grade A
Q: The protocol and protocol summary have been submitted to a central IRB/IEC for
review/approval by the CRO prior to the investigators’ meeting. Following the meeting, the entry
criteria are altered to facilitate the recruitment and retention of eligible subject. Prior to trial startup, the regulatory binder must include:
1.An IRB/IEC letter of approval for the amended protocol
2.An IRB/IEC site evaluation form
2.The amended protocol

4. The investigator’s brochure
   A. 1, 2, and 3 only B. 1, 2, and 4 only C. 1, 3, and 4 only
   D. 2, 3, and 4 only
   Answer:
   C

• References: E6 4.4; E6 4.5.2; E6 4.9.4; E6 8.2.7
• Of the 4 choices, choice #2 – “an IRB/IEC site evaluation form” is the only document not
  specified to the amendment or IP and not a required regulatory document. Option C is the only
  answer that does not include document #2
  Q: A subject is participating in a lipid-lowering clinical trial. Before his
  12-month visit, the CRC receives an amendment from the sponsor that in- cludes an outcomes
  measurement instrument at the 12-month visit. The CRC should FIRST provide the subject with
  which of the following?
  A. An amendment for the subject’s signature
  B. A revised consent form
  C. A copy of the outcomes measurement instrument
  D. An interpretation of the items on the instrument
  Answer:
  B
• References: 4.8.2
• A is incorrect: Subjects do not sign amendments
• B is correct: Of these options, this is the document that is signed by a subject
• C is incorrect This item is intended for either the investigator or the sponsor/data management
• D is incorrect: This item is intended for either the investigator or the sponsor/data management

Q: Which of the following scenarios are considered SAEs?
1.Infection following surgery prolonging hospital stay
2.Pregnancy resulting in normal delivery of twins
2.Boating accident with overnight hospitalization

4. Use of illicit drugs during the trial
   A. 1 and 3 only B. 1 and 4 only C. 2 and 3 only
   D. 2 and 4 only
   Answer:
   A

• References: E6 1.50, E2A IIB
• Note: per ICH guidelines E6 1.50 Serious Adverse Event (SAE) or Serious Adverse
  Drug Reaction (Serious ADR) is defined as any untoward medical occurrence that at any dose
  results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing
  hospitalization (scenarios #1 and #3), results in persistent or significant disability/incapacity, or
  is a congenital anomaly/birth defect
• 1 is correct – prolongation of existing hospitalization
• 2 is incorrect – pregnancy is not an SAE
• 3 is correct – inpatient hospitalization
• 4 is incorrect – not an SAE
• A is correct since it is the only option that contains both 1 and 3
  Q: A subject in a Phase I oncology trial experiences nausea with vomiting after IP infusion
  which results in an inpatient hospitalization. Nausea with vomiting does not appear in the
  investigator’s Brochure. The investigator should rate this event as:
  A. Expected and serious
  B. Expected and not serious
  C. Unexpected and serious
  D. Unexpected and not serious
  Answer:
  C
• References: E2A II.A.3; E2A IIB; E2A III.A.1
• Since, as stated in the stem of the question, nausea with vomiting does not appear in the
  Investigators’ Brochure, it meets the criteria of “unexpected.” The event is also considered
  “serious” as inpatient hospitalization meets the definition of a Serious Adverse Event per ICH
  guideline E6 1.50
• A is incorrect: this event is unexpected
• B is incorrect: this event is unexpected and serious
• C is correct: this event is unexpected and serious
• D is incorrect: this event is serious
  Q: During a respiratory trial, a subject called the CRC 1 week before his next scheduled trial
  visit and reports upper respiratory symptoms and a pea-sized lump in his neck. Which of the
  following should the CRC do FIRST?
  A. Inform the sponsor’s medical monitor or the situation
  B. Instruct the subject to contact his primary care physician
  C. Have the subject come to the site for an interim assessment
  D. Cancel the scheduled follow-up visit until symptoms resolve
  Answer:
  C
• References: E6 4.3.2
• A is incorrect: the subject needs to be assessed before the sponsor is contacted
• B is incorrect: the investigator, not the primary care physician, should ensure that adequate
  medical care is provided to the subject for and adverse event
• C is correct: in the given scenario, the subject needs to be evaluated by the investigator so that
  adequate medical care can be provided and relatedness of the
  AEs to the clinical trial can be assessed
• D is incorrect: the subject needs to be evaluated as subject’s safety should always be the
  primary concern in clinical care, particularly in the context of a clinical trial
  Q: Which of the following is a liver function test? A. TSH
  B. LDH C. BUN
  D. Hct
  Answer:
  B
• A is incorrect: Thyroid Stimulating Hormone – test used to assess the function of the thyroid
  gland
• B is correct: Lactate Dehydrogenase – test used to check for damage to the tissue of the heart,
  liver, kidney, muscles, brain, blood cells, and lungs
• C is incorrect: Blood Urea Nitrogen – kidney function test
• D is incorrect: Hematocrit – blood test measuring the percentage of the volume of whole blood
  that is made up of red blood cells.
• NOTE: to be certified, candidates are expected to have a general knowledge of laboratory
  terminology, tests, and procedures

Q: At the month-3 visit of a Phase III double-blind trial, the subject informs the CRC that he
was seen in the emergency department for an anaphylactic reaction. The subject states, “The
doctor told me I was very lucky, I might have died.” Having received this information, the
MOST appropriate sequence of action is to inform the:
A. PI, sponsor, and IRB/IEC B. Sponsor, PI, and IRB/IEC C. Sponsor, IRB/IEC, and PI
D. PI, IRB/IEC, and sponsor
Answer:
A

• References: E6 4.11.1
• A is correct: The study PI should be notified first ash they are responsible for
  the subject’s wellbeing while on the clinical trial and should ensure that adequate medical care is
  provided to the subject for all adverse events. Per ICH guidelines, all SAEs should be reported
  immediately to the sponsor and to the IRB/IEC per applicable regulatory requirements.
• B is incorrect: it would not be appropriate to notify the sponsor before making the
  PI aware of subject reported safety information
• C is incorrect: it would not be appropriate to notify the sponsor before making the
  PI aware of subject reported safety information
• D is incorrect: per ICH guidelines, all SAEs should be reported immediately to the study
  sponsor and to the IRB/IEC per applicable regulatory requirements
  Q: A subject is being screened for an allergic rhinitis trial. At the screening visit, the CRC
  obtains a BP of 200/100 mm Hg. The subject states she has not had a problem with hypertension
  and does not take hypertension medication. The CRC checks the inclusion and exclusion section
  of the protocol and does not find hypertension to be an exclusion criterion. What should be the
  next step for the CRC?
  A. Call the sponsor
  B. Document this as an AE C. Discontinue the subject
  D. Recheck the blood pressure
  Answer:
  D
• References: E6 4.5.1
• A is incorrect: this situation does not warrant a call to the sponsor
• B is incorrect: this is the NEXT step the CRC would take
• C is incorrect: hypertension is not exclusionary
• D is correct: blood pressure reading of 200/100 is clinically concerning for a subject with no
  history of hypertension. The blood pressure should be rechecked to verify the reading’s accuracy
  before going any further
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Which of the following documents are most cited when conducting human subject research?A. Food Drug & Cosmetic Act, Declaration of Helsinki, and the Belmont ReportB. Food and Drug Law, Nuremburg Code, and the Public Health CodeC. Declaration of Helsinki, Nuremburg Code, and the Belmont Report C. Declaration of Helsinki, Nuremburg Code, and the Belmont Report
Which historical document discusses the purpose of the Internal Review Board?A. The Nuremburg CodeB. Declaration of HelsinkiC. 21 CFR Part 11C. Belmont Report B. Declaration of Helsinki
A pharmacoeconomic study is an example of what type of study?A. ExploratoryB. ConfirmatoryC. Post ApprovalD. Human pharmacology C. Post Approval
A pharmacokinetic study is an example of what type of study?A. ExploratoryB. ConfirmatoryC. Post ApprovalD. Human pharmacology D. Human pharmacology
“At the month 3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states, “”The doctor told me I was very lucky, I might have died.”” Having this information, the MOST appropriate sequence of action is to inform the:A. PI, sponsor, IRB/IECB. Sponsor, PI, IRB/IECC. Sponsor, IRB/IEC, PID. PI, IRB/IEC, sponsor” A. PI, sponsor, IRB/IEC
The purpose of the IRB is to:A. Inform study subjects about the protocol and experimental drugB. Respect the rights and welfare of human subjects in researchC. Ensure sponsors are meeting FDA regulationsD. Write easily understood consent forms B. Respect the rights and welfare of human subjects in research
Which of the following would generally indicate the breaking of a randomization code in a blinded study?A. The participant withdraws from the study prior to its conclusionB. Only participants at one of the sites shows any definitive response to treatmentC. A participant experiences an SAE, the etiology of which cannot be explained (or anticipated) C. A participant experiences an SAE, the etiology of which cannot be explained (or anticipated)
The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the IM. Following the meeting, the eligibility criteria are altered to facilitate the recruitment and retention of eligible subjects. Prior to trial start-up, the regulatory binder must include:1. An IRB/IEC letter of approval for the amended protocol2. An IRB/IEC site evaluation form3. The amended protocol4. The Investigator’s Brochure A. 1 & 2B. 2 & 4C. 1 & 3D. 3 & 4 C. 1 & 3
The CRC reviewed a new protocol to prepare the trial budget for submission to the sponsor. According to the protocol, each subject is required to return for follow-up visits at 30 days, 6 months, and 1 year. – At 30 days, protocol requires a physical exam, ECG and chest x-ray- At 6 months, the protocol requires a physical exam and ECG- At 1 year, the protocol requires a physical exam, ECG, and chest x-rayThe hospital charges $75 for physical exams, $50 for ECG and $100 for chest x-rays. The 30 day and 1-year visits are considered SOC. How much should the CRC budget per year for the non-SOC visits?A. $125B. $225C. $450D. $575 A. $125
A study treatment requires subjects to return every 14-16 days; dosing is 2 tablets, 4 times a day. How many tablets should be in the bottle?A. 112B. 148C. 158D. 128 D. 128
A study treatment requires subjects to return every 14-16 days; dosing is 2 tablets, 4 times a day. A subject returns for study visit and has 16 tablets left. Were they compliant?A. yes, if day 14B. no, if day 14C. yes, if day 16D. no, if day 16 A. Yes, if day 14
The subject forgets to return study drug. Do you:A. Dispense the next treatment, have subject return both medicines at next visitB. Hold treatment until subject returns drugC. Have subject finish tablets left at home and return for the next bottle when first is emptyD. None of the above A. Dispense the next treatment, have subject return both medicines at next visit
The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the Untied States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.A. TrueB. False A. True
The purpose of the IRB is to:A. Inform study subjects about the protocol and drugB. Protect the rights and welfare of human subjects in researchC. Ensure sponsors are meeting FDA regulationsD. Write easily understood consent forms B. Protect the rights and welfare of human subjects in research
What is the minimum number of members required by an IRB?A. 8B. 6C. 2D. 5 D. 5
Which of the following are necessary to waive consent?A. Subject is unable to give consentB. No time or unable to contact next of kinC. Life-threatening conditionD. No other treatment availableE. All of the above E. All of the above
Ethical principals of respect for persons, beneficence and justice are outlined in:A. 45 CFR 46B. The Belmont ReportC. The Nuremburg CodeD. Declaration of Helsinki B. The Belmont Report
Informed consent is documented by:A. A written, signed, and dated informed consent formB. A witness signatureC. The IRB chairpersonD. The InvestigatorE. The subject’s legally authorized representative A. A written, signed, and dated informed consent form
Informed consent documents must include the following:A. a statement that the study involves researchB. a statement of possible riskC. a discussion of possible alternative treatmentsD. all of the above D. all of the above
The responsibility of the participants safety lies with:A. sponsorB. PIC. IRB B. PI
A drug’s safety is determined by which of the following criteria:A. the dose at which no side effects are reportedB. the absence of harmful side effects on the individuals exposed so farC. the FDA’s review of source documentation at a clinical site B. the absence of harmful side effects on the individuals exposed so far
“Which of the following terms is best defined as “”a pharmaceutical preparation that contains no active agent””A. blindedB. non-invasiveC. placebo” C. placebo
which of the following design methods would best be used for a study keeping both the subject and the PI/site staff from knowing which treatment the subject is receiving?A. double blindedB. interpretive biasC. bias reduction A. double blinded
which person(s) or agency would not be informed of the treatment assignment for a subject in a study using a single blind method of randomization?A. the subjectB. the research teamC. the FDA A. the subject
What is the primary reason for blinding individuals or groups to the assigned treatments in a clinical trial?A. it decreases the amount of unnecessary data collectionB. It is intended to eliminate biasC. It is the only way to ensure accurate results B. It is intended to eliminate bias
the PI must obtain IRB approval of the study and the consent form:A. before the study has been completedB. before enrolling any patientsC. before receiving any grant money for the studyD. before the first patient has completed the study B. before enrolling any patients
which of the following responsibilities falls under the jurisdiction of the FDA?A. oversight of regulation adherence in clinical trialsB. approval of individual study sitesC. direct management of clinical trials A. oversight of regulation adherence in clinical trials
“The FDA does not require the use of a written assent form; however, when a written assent process is appropriate or required by the IRB, the FDA strongly encourages the use of a separate assent form that is “”child-oriented”” and developmentally appropriate. A. TrueB. False” A. True
_ is not a basic element of informed consent.A. description of clinical investigationsB. voluntary participationC. contactsD. number of participants D. number of participants when a short form is used for informed consent, the witness must sign either the short form or the summaryA. trueB. false A. true the records of a subject who was previously enrolled in a clinical trial may be reviewed retrospectively, without reconsent, to collect additional information under certain limited circumstance, consistent with the original consent process.A. trueB. false A. true the form is the application for investigational new drugs (IND)A. 1571B. 1572C. 3500A A. 1571
what is a person or organization contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?A. CRO – contracted research operationsB. CRO – clinical research organizationC. CRO – center for research operationsD. CRO – contracted research organization D. CRO – contracted research organization
“the immediate package of an investigational new drug intended for human use shall bear a label with the statement:A. “”caution: for FDA research purposes only””B. “”caution: new drug – limited known side effects””C. “”cation: new drug – limited by federal (or US) law to investigational use””D. none of the above” “C. “”cation: new drug – limited by federal (or US) law to investigational use”””
the international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as:A. ICHB. good clinical practice (GCP)C. fundamental ethical principalsD. the declaration of HelsinkiE. FDA code of federal regulations (CFR) B. good clinical practice (GCP)
A(n) is a printed, optical or electric document designed to record all of the protocol required information to be reported to the sponsor on each trial subject:A. SAEB. 1572C. CRF C. CRF
Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the:A. mission statement of the ICHB. mission statement of the declaration of HelsinkiC. mission statement of the GCP guidelinesD. mission statement of Canada Health C. mission statement of the GCP guidelines
what are the three fundamental ethical principals for human subjects research?A. informed consent for participation in researchB. fair distribution of cost/benefit ratioC. maximizing benefits, minimizing risksD. autonomy of patientsE. respect for personsF. non-exploitative and well-considered proceduresG. justiceH. beneficence E. respect for personsG. justiceH. beneficence
Who monitors the progress of all clinical trial investigations being conducted under its IND?A. sponsorB. PIC. IRBD. CRO A. sponsor
Class 3 devices…A. no potential for risk or injuryB. require premarket approvalC. support or sustain lifeD. B & C D. B & C
An unexpected SAE involving a fatal or life threatening AE must be reported to the FDA no later than calendar days after the sponsors initial report of the information.A. 5B. 10C. 7D. 30 C. 7
For initial approval of proposed research, the investigator must submit to the IRB:A. A protocol synopsis and Investigators BrochureB. The informed consent and protocol synopsisC. The full protocolD. The full protocol and informed consent D. The full protocol and informed consent
the process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as:A. HIPAA authorizationB. IRB approvalC. Legally authorized agreementD. Intent to treatE. Informed consent E. Informed consent
which signatures are required by regulation to be on the consent form?A. the PIB. the subjectC. the PI and the subjectD. the subject and the witnessE. the PI, the subject, and the witness B. the subject
ICH guidelines provide a unified standard for _ clinical trials involving human subjects.A. designingB. conductingC. recordingD. reportingE. all of the above E. all of the above
phase 1 studies may be conducted in .A. patientsB. animalsC. normal volunteer subjectsD. A & C D. A & C
“what are the two main themes covered by the formal ICH definition of “”good clinical practice””?A. right and well-being of study subjects and compliance with regulationsB. rights and well-being of study subjects and credibility of dataC. compliance with regulations and credibility of the dataD. compliance with the regulations and the formal marketing approval processE. credibility of the data and international consistency” B. rights and well-being of study subjects and credibility of data
waivers of consent cannot be used when:A. research is FDA-regulatedB. subjects have no capacity to consent and time is limited (emergency)C. in vitro diagnostic device studiesD. studies are minimal risk A. research is FDA-regulated
non-clinical studies refer to studies that do not involve:A. animal testingB. drugsC. human subjectsD. toxicology parametersE. safety C. human subjects
Which drug development phase might consist of normal, healthy volunteers that are given a new drug?A. phase IB. phase IIC. phase IIID. phase IIBE. phase IV A. phase I
larger, multicenter studies are usually done in:A. phase IB. phase IIC. phase IIID. phase IIBE. phase IV C. phase III
By regulation, an investigator must keep records relating to:a. disposition of the study drugb. case historiesc. case report formsd. signed informed consent formse. all of the above e. all of the above
Most sponsors will expect an investigative site to keep all study records for how long?a. 15 yearsb. 3 yearsc. 5 yearsd. until the sponsor says they must be destroyede. two years after the last subject finished treatments d. until the sponsor says they must be destroyed
which of the following would not indicate an observational study?a. investigator assessing health outcomes in a group according to a protocolb. investigator assigns a medical product to individuals as part of his research designc. investigator is looking at eating habits of children and its association to hyperactivityd. investigator is looking at cognitive recovery after SOC anesthesia regimen b. investigator assigns a medical product to individuals as part of his research design
a source document is any document where:a. lab values are shownb. HIPAA authorization was receivedc. data are first recordedd. a subject’s name is showne. sponsor access to the document is not allowed c. data are first recorded
standard operating procedures are essential for:a. standardizing processesb. ensuring the regulatory requirements are metc. training new personneld. managing workloade. all of the above e. all of the above
financial disclosure applies to:a. only the PIb. the PI and CRCc. anyone at the site who is involved in the triald. only those people listed on the 1572e. the PI, CRC, and pharmacist d. only those people listed on the 1572
payments to subjects in clinical trials should:a. never be doneb. be done only for phase 1 trials c. be done only with prior IRB approvald. be done only once, at the end of a subjects trial involvemente. never be more than $100 for completing a study c. be done only with prior IRB approval
potential reasons to discontinue a subject in a trial are:a. the subject is not compliant with study proceduresb. the subject has an intolerable medical event during treatmentc. pregnancyd. A & Be. A, B & C e. A, B & C
by regulations, investigators are required to make final study reports to:a. the FDA and sponsorb. sponsor and IRBc. the institutiond. sponsor, IRB, and FDAe. the sponsor b. sponsor and IRB
there are two main reasons that a sponsor might audit a study site. They are:a. the IRB has requested a sponsor auditb. to ensure the site is complying with the regulations and protocolc. there is evidence that the site is out of compliance and the sponsor wants to verify whether or not this is trued. A and Be. B and C e. B and C
there are 3 classifications that result from an FDA audit. The one that means deviations from regulations were found but they were not serious is:a. VAIb. NAIc. OAId. BIMO-2e. EIR a. VAI
which of the following is not listed on FDA form 1571:a. name, address, phone number of sponsorb. a commitment not to start the clinical investigation until the IND is in effectc. identification of the phase of a triald. approved informed consent document d. approved informed consent document
a contract research organization shall be responsible for .a. obtaining information from the investigatorb. control of the drugc. selecting investigatorsd. all of the above d. all of the above
a lists the investigator’s education, training, and experience that qualifies them as an expert in the clinical investigation of the drug for the use under investigation.a. CVb. letter from fellow investigatorc. statement or qualifications of the investigatord. a and c d. a and c
if no subjects are entered into clinical studies for a period of 1 year or more under an IND, the IND may be placed on inactive status by the FDAa. trueb. false b. false (2 years)
_ are the two most important design techniques for avoiding bias in a clinical triala. randomization and stratificationb. randomization and unblindingc. randomization and endpointsd. randomization and blinding d. randomization and blinding
if the study is submitted in support of an IND, the records must be kept for _ after the date the marketing application is approved.a. 1 yearb. 2 yearsc. 3 yearsd. eternity b. 2 years a protocol is required to contain .a. a description of the observations and measurements to fulfill the study’s objectivesb. a description of the clinical procedures and lab proceduresc. a statement of the objectives and purposed. all of the above d. all of the above
the FDA shall provide a written determination after the FDA receives the IND or earlier.a. 15 daysb. 30 daysc. 2 monthsd. 1 year b. 30 days
phase 4 studies could include .a. using the drug over a longer period of timeb. use of the drug in other patient populationsc. use of the drug in other disease stagesd. all of the above d. all of the above an IEC/IRB ensures the protection of of human subjects in a clinical trial.a. safetyb. rightsc. well-beingd. all of the above d. all of the above
A must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the clinical investigation.a. advocateb. parentc. witnessd. none of the above a. advocate if the short form method is utilized, the witness shall sign _.a. copy of the summaryb. short formc. short form and copy of summaryd. consent form c. short form and copy of summary
the formal evaluation of the quantitative evidence from two or more trials bearing the same questions is known as a .a. interim analysisb. meta-analysisc. blind reviewd. analysis plan b. meta-analysis The sponsor shall notify the FDA by telephone or fax any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but no later than after the sponsor’s initial receipt of the informationa. 7 working daysb. 14 calendar daysc. 7 calendar daysd. 21 working days c. 7 calendar days
“””life-threatening”” means:a. diseases or conditions where the likelihood of death is high unless the course of the disease is interruptedb. diseases or conditions with potentially fatal outcomes, where the end point of the clinical trial analysis is survivalc. none of the aboved. a and b” d. a and b
any individual assisting with the management of a study including consenting subjects or extracting data should be listed as key personnel.a. trueb. false a. true
the person who obtains informed consent of a subject must:a. have IRB approval to consent subjectsb. complete blanks for the subjectc. sign as the witnessd. be the PI of the study a. have IRB approval to consent subjects
The individual responsible for ensuring that data queries are reviewed and clarified at the study site is the:A. Sub-IB. Study pharmacist C. Study coordinator D. PI D. PI
An ICF was sent home with a potential study subject on Friday with a visit scheduled for Monday. The subject signed and dated the ICF over the weekend. On Monday, the CRC notices while discussing the informed consent document. Which is the MOST appropriate action for the CRC to take?A. Notify PI and sponsor of event B. Submit a discrepancy report to the IRBC. Reconsent the subject with a new ICF with a notationD. Sign and date the ICF during the Monday visit C. Reconsent the subject with a new ICF with a notation
If a sponsor discovers that data was deliberately falsified, which of the following is most likely to happen immediately? A. All sites will be closedB. The Sub-I will be appointed as PIC. the PI will be prevented from practicing medicineD. No further IP will be sent to the PI D. No further IP will be sent to the PI
Which of the following is PHI that requires compliance with HIPAA prior to transmitting?I. age in yearsII. medical record numbersIII. date of deathIV. addressA. I, II, and III onlyB. I, II, and IV onlyC. I, III, and IV onlyD. II, III, and IV only D. II, III, and IV only
The type of clinical trial designed to prevent PIs from assigning those patients whom they think have the best prognosis is to what they believe is the superior therapy is:A. randomizedB. stratifiedC. outcomes studiesD. blinded control A. randomized
During the course of a clinical study, which of the following items would a sponsor most likely reimburse a site?A. an increase in subject stipendB. additional tests or visits due to an AEC. a hospitalization occurring during a studyD. prescriptions ordered during study participation B. additional tests or visits due to an AE
Which of the following might be considered sources in order for determining local lab costs?1. previous budget with this sponsor2. laboratory director3. PI4. lab fee schedule A. 1 and 3B. 1 and 4C. 2 and 3D. 2 and 4 D. 2 and 4
As a CRC coordinating a cardiac medical device study, which of the following would generally be considered the most qualified person to monitor your site?A. a cardiologist not associated with the PIB. the engineer who developed the deviceC. a nurse with an understanding of the study and monitoring experienceD. the IRB/IEC chairperson C. a nurse with an understanding of the study and monitoring experience
Which of the following items should be included in the formal closeout report from the site to the IRB?1. total number of subjects enrolled2. date the IRB approved the study3. date the last subject was enrolled4. total number of adverse events that occurredA. 1, 2 and 3B. 1, 3 and 4C. 2, 3, and 4D. 1, 3, and 4 D. 1, 3, and 4
According to CFR, which of the following must the investigator report to the IRB?A. any subjects considered lost to follow upB. disclosure of any financial interests in the sponsor of the studyC. a protocol change reducing the number of blood draws C. a protocol change reducing the number of blood draws
When advertising for research subjects in a local newspaper, which of the following are most appropriate to be included?A. required age, gender, and diagnosis of eligible subjectsB. possible benefits of participation, including improvement of diseaseC. name of sponsorD. name of study drug “A. required age, gender, and diagnosis of eligible subjects(“”improvement of disease”” is not allowed, as this has not been confirmed)”
If a subject in a long-term, open-label maintenance study requires a knee replacement surgery, which of the following is true?A. it is not necessary to file an SAE reportB. the subject may continue with no interruption in study medication assuming the study is in Phase IIIBC. the sponsor should determine if the subject should remain in the studyD. the admitting hospital’s IRB must give approval for the subject to continue the study medication C. the sponsor should determine if the subject should remain in the study(SAE likely required due to long hospital stay; phase of study doesn’t matter)
A CRC has been obtaining informed consent. They are keeping the original consent form for the PI, and giving a copy to the subject. What else should the PI ensure is carried out?A. documenting in the case history that informed consent was obtained prior to the conduct of any research-related procedure.B. having the CRC date all the signatures on the ICFC. putting copies of the ICF in the subject’s medical recordsD. providing a copy of each signed ICF to the IRB A. documenting in the case history that informed consent was obtained prior to the conduct of any research-related procedure
A 15 year old wants to screen for a study. She is on spring break and her parents have given verbal permission. Her grandma brings her in for the screening visit with a letter from her parents approving medical care. Can she be screened for the study?A. no, a legal guardian must be present to sign the ICFB. yes, the grandma may sign as the legal guardianC. yes, the grandma may sign the ICF and attach the parents’ permission letter D. Yes, anyone over 18 who brings a child in as under their custody may sign the ICF A. no, a legal guardian must be present to sign the ICF
The CRC at a site sends in weekly screening logs for an osteoporosis study for which recruitment continues to be a site-specific problem. Which of the following would be the LEAST likely cause of the site’s low enrollment?A. the study budget is too lowB. The clinic is not open on SaturdaysC. subjects screened are too young for the disease under investigationD. the CRC is running too many studies B. The clinic is not open on Saturdays
A PI has become a member of the local IRB and is conducting a study approved by the same IRB for which enrollment began 6 months ago and will continue for an additional 24 months. The CRC is submitting a protocol amendment, which will be reviewed/approved by the IRB. The CRC should be aware that the:A. IRB chair must allow the PI to deliberate and voteB. PI must abstain from the deliberation and voting processC. IRB chair must allow the CRC to deliberate and vote in place of the PID. PI must abstain from the investigator duties during the deliberations and voting process B. PI must abstain from the deliberation and voting process
A PI requests that the CRC maintain the IP accountability log in the research office, even though a pharmacy is responsible for storing and dispensing study drug. The CRC may best respond to this request byA. maintaining the accountability log in her office according to regulationsB. explaining to the PI that the log should be maintained in the pharmacy where the IP is dispensedC. requesting that the monitor explain the regulations regarding the responsibilities and obligations of the PID. suggesting the PI read the regulations related to storage and dispensing of IP B. explaining to the PI that the log should be maintained in the pharmacy where the IP is dispensed
When does a study site become responsible for submitting IND safety reports to the IRB?A. after subject screening procedures beginB. after the first subject enrollsC. after the test article is receivedD. as soon as reports are received from the sponsor D. as soon as reports are received from the sponsor(IND safety reports are sent to sites by the sponsor updating safety info in the IB. These are submitted to the IRB as soon as they’re received)
A subject dies 2 days before a long-term follow-up visit and had been off the study drug for 2 weeks. This would be reported asA. an AEB. an SAEC. a side effectD. early termination B. an SAE
According to the CFR, an unexpected adverse drug experience (ADE) isA. one that occurs occasionally in a subgroup of subjects, but is not believed to be associated with the IPB. one that is not identified in nature, severity, or frequency in the current labeling, IB, general investigational plan, or elsewhere in the INDC. any reaction that’s listed in the IB, but is not listed in the Product Labeling due to infrequency of occurrence D. a fatal or an immediately life-threatening clinical experience, birth malformation, permanently disabling event, any event that requires prolonged inpatient hospitalization B. one that is not identified in nature, severity, or frequency in the current labeling, IB, general investigational plan, or elsewhere in the IND(D is an SAE)
If a subject is hospitalized for more than 24 hours during the course of a study due to a fractured arm, it would be consideredA. an SAEB. an AEC. an accidentD. drug-related A. an SAE
During a phase III study, a subject develops a systemic rash one day after administration of IP, which is the first event of it’s kind. Based only on the info given, the AE is most likely reportable as:A. an SAEB. an unexpected AEC. an adverse drug reactionD. a severe adverse event B. an unexpected AE(we don’t know that it’s related to IP as it’s the first event, so not C; we don’t know the severity, so not D)
During her first week on IP, a study participant called the site to report she had a generalized itchy rash, which has caused extreme discomfort. What is the best course of action for the CRC to take in this case?A. stop IP immediatelyB. tell her to come into the office for an interim visitC. tell her to keep track of the rash for an accurate history at the next study visitD. tell her to take benadryl B. tell her to come into the office for an interim visit
According to ICH guidelines, an adult who is illiterate may be considered as a subject for a clinical study under which of the following circumstances?A. under no circumstancesB. with an impartial witness signature on the ICFC. if the subject can understand the oral consent and sign with an XD. provided the subject’s LAR witnesses the informed consent B. with an impartial witness signature on the ICF
A site is involved in a clinical trial involving emergency research of a potentially life-saving device. A subject arrives unconscious to the ER following trauma and meets the eligibility criteria of the trial. Who has the authority under these circumstances to waive the ICF requirements so the subject may enroll?A. the PI and a physician associated with the IRBB. the PI and a sponsor representative C. the PI and an independent physicianD. the subject cannot enroll A. the PI and a physician associated with the IRB
A site has been participating in a trial for 11 months. In preparation for an upcoming monitoring visit, the CRC reviews the regulatory document binder to identify any outstanding issues. Which of the following is the most important regulatory document for the CRC to examine?A. financial disclosure updatesB. IRB approvalC. FDA form 1572D. screening logs B. IRB approval(since the site has been participating for almost 12 months, the IRB continuing approval needs to be in the binder)
When may a PI break the blind without pre-approval by the sponsor?A. after the study is completedB. if an SAE occursC. when subject safety is jeopardizedD. if the subject requests to know C. when subject safety is jeopardized
A subject who intentially overdosed is treated in the ER and released after 22 hours of observation. Per ICH guidelines, what would the CRC be required to do?A. notify the sponsor within 24 hoursB. notify the IRB immediatelyC. document as an SAED. document as an AE D. document as an AE
A screening procedure that qualifies as minimal risk in a study that is considered to present greater than minimal risk requires:A. no consentB. screening consentC. full consentD. IRB acknowledgement C. full consent
A subject in a hormone replacement study has an AE of breakthrough bleeding at the completion of the study. The subject is referred to her PCP for follow-up. 2 months later, the PCP calls and wants to know what the subject was taking while in the study. The sponsor suggests that the blind not be broken. Which of the following should the CRC do?A. do not break the blind and have the PI call the PCPB. get the subject’s permission and then break the blindC. do not break the blind, but immediately notify the IRB of the requestD. get the PI’s permission and then break the blind A. do not break the blind and have the PI call the PCP
A sponsor provides an informed consent sample to potential study sites in order to:A. fulfill the FDA obligationB. satisfy the PI’s demandsC. inform the IRB of the correct versionD. document the appropriate consent content D. document the appropriate consent content
A subject on an oral birth control study calls the CRC to tell them she has a positive pregnancy test. What should the CRC do first?A. inform the PI and report the event to the sponsor as an SAEB. Have the subject repeat the test at home and notify the clinic of the resultsC. Request that the subject come in early for her next visit to check compliance D. instruct the subject to withhold the IP and come in for a serum pregnancy test immediately D. instruct the subject to withhold the IP and come in for a serum pregnancy test immediately(at home tests have a good degree of false positives, so she should get a blood test done at the clinic; discontinue IP to avoid any untoward effects on the fetus; pregnancy itself is not an SAE)
According to FDA regulations, which of the following is the best example of a vulnerable subject?A. a nunB. a pregnant womanC. an HMO participantD. a long-time patient of the PI B. a pregnant woman
In qualifying a patient for entry to a trial, the CRC notices slightly elevated liver enzymes on the lab report. The protocol states that subjects with clinically significant deviations from reference range values should be excluded. What would be the appropriate course of action?A. allow the subject to continue and monitor liver enzymes carefullyB. inform the subject about the result and request a waiver from the medical monitorC. notify the subject that he/she isn’t eligibleD. retest liver enzymes immediately to confirm initial lab results A. allow the subject to continue and monitor liver enzymes carefully(lack of CS; if CS, seeking waiver from sponsor would be correct)
A CRF requires metric documentation of height and weight. A subject weighs 150 lbs and is 5 ft 5 inches tall. Which of the following would the CRC document in the CRF?A. 60 kg and 143 cmB. 68 kg and 165 cmC. 72 kg and 170 cmD. 75 kg and 180 cm B. 68 kg and 165 cm(weight divided by 2.2; total inches (65in) times 2.54)
“After signing a consent form for a double-blind, placebo-controlled study, the subject says “”I know this medicine will cure me””. This statement may indicateA. the subject wants access to the IP without participating in the trialB. the subject is of the impression that this study involves a marketed drugC. the subject may have signed the informed consent form under duressD. the subject does not fully understand the study” D. the subject does not fully understand the study
Which of the following are considered tasks the CRC would complete prior to the routine monitoring visit?1. review the CRF to ensure all data to date has been transcribed2. enter all projected visit dates on the enrollment log3. send original CRF pages to CRA for review4. record IP dispensation completed to dateA. 1 and 3B. 1 and 4C. 2 and 3D. 2 and 4 B. 1 and 4
A subject has been enrolled under an emergency use of an IP. Within how many working days should the IRB be notified?A. 1B. 3C. 5D. 7 C. 5
The CRC decides to create a telephone call worksheet to capture events between the in-person study visits. She identifies the following items as important information to obtain:1. confirmation of date of next study visit2. reports of major medical events3. compliance in taking the IP4. changes in concomitant meds5. visits to PCPThe CRC decides she should also share this info with the PI. Which of these events are the most important to share with the PI?A. 1, 2 and 4B. 1, 3, and 5C. 2 and 5D. 3 and 4 C. 2 and 5
The difference between a short-form informed consent and the regular informed consent is that a short-form:A. is presented orallyB. requires 2 witnessesC. must be signed by the person obtaining consentD. is a written summary provided to the subject A. is presented orally
An ICF is changed to reflect an additional interim visit at month 6. Current subjects have completed the month 8 visit. Which of the following subjects should sign the new consent document?A. all active subjectsB. all active and completed subjectsC. subjects who enter the study after the changeD. subjects who are still active in the study and are past month 6 C. subjects who enter the study after the change
Which of the following is false regarding the trial initiation visit report?A. it must be separate from the pre-trial monitoring visit reportB. a copy of the report should be put in the site fileC. it should document that all trial related procedures were discussedD. it may be replaced by the investigator meeting minutes A. it must be separate from the pre-trial monitoring visit report(IM’s commonly replace SIVs; meeting minutes can serve as documentation of the discussion/training that occurred)
A CRC and PI are opening an evening clinic to accelerate recruitment for an osteoporosis trial. 20 women are scheduled for a screening visit, which includes a DEXA, lab work, PE, and ECG. After getting ICFs signed, all subjects must be registered in order to obtain an MRN. There are 5 exam rooms available. What is the minimum staff mix required to minimize subject waiting time and overhead costs?A. 2 CRCs, 1 DEXA tech, phlebotomist B. 1 CRC, 1 DEXA tech, 1 ECG techC. PI, 1 CRC, 1 DEXA tech, 1 ECG tech, phlebotomist C. PI, 1 CRC, 1 DEXA tech, 1 ECG tech, phlebotomist (PI and CRC obtain consent; while CRC registers patient, PI conducts PE while phlebotomist draws lab and DEXA and ECG techs perform their jobs)
At the IM, the CRC reviewed IP accountability where subjects must maintain 80% compliance to remain eligible. Subjects are required to take 2 tabs of IP BID. After 12 weeks, a subject considered 80% compliant would have takenA. 270 tabsB. 269 tabsC. 336 tabsD. 337 tabs B. 269 tabs(4 tabs per day x 7 days/week = 28 tabs per week. 28 x 12 weeks = 336 for 100% compliance. 336 x 80% = 269
A sponsor provides a CRC a newspaper ad approved by the central IRB. The CRC works for a private practice PI who is not required to use the local IRB. Which of the following should be the CRC’s next step?A. do not use the ad until neededB. place the ad in the local paperC. submit the ad to the local IRBD. revise the ad to make it less generic B. place the ad in the local paper
A study conducted 5 years ago has recently been denied FDA marketing approval. After the PI receives the sponsor’s notification letter, the PI wants to arrange for immediate destruction of the study files. The CRC’s first response should be:A. immediately place a call to the shredding company to make these arrangementsB. remind the PI of the requirement to retain records for another 2 yearsC. recommend that the PI call the sponsor firstD. ignore the request and do nothing C. recommend that the PI call the sponsor first(requirement for PIs to keep study files for 2 years following the date a marketing application is approved/denied. The PI should get the sponsor’s direction in writing)
Prior to a patient is scheduled to be dosed, the CRC determines the IP has not been properly stored. The CRC shouldA. approve the dosing and write the finding in the monitoring reportB. obtain approval from medical monitor prior to dosingC. delay dosing for a few hours and place IP in the fridge (per protocol) to cool to the desired tempD. postpone dosing until the site receives a new batch of study medication D. postpone dosing until the site receives a new batch of study medication (IP may not be safe to dispense if it isn’t stored properly)
A PI shall submit to the sponsor and IRB a report of any unanticipated adverse device effect occurring during an investigation and/or after the investigator learns of the effect, as soon as possible, but in no event later than:A. 5 working daysB. 10 working daysC. 15 working daysD. 30 working days B. 10 working days(device regulations require 10 working days. Drugs require 15 calendar days)
A healthy subject reports several headaches at visit 3. The subject states she typically gets these around her period. The headaches were not previously mentioned. The CRC should1. document the headaches as an AE2. add the period-related headaches to the source doc3. notify the CRA at the next visit4. amend the original medical history page in the CRFA. 1 and 2B. 2 and 4C. 1, 3. and 4D. 2, 3, and 4 D. 2, 3, and 4(not an AE as this is part of medical history; CRFs would need to be updated with the date of notification)
A subject in a hypertension study has completed treatment. The patient, who has a hx of gallstones, eats a large amount of BBQ and has a gallbladder attack that requires immediate surgery. What is the CRC’s best course of action?A. nothing. the patients is 30 days post study, so this is not a study SAEB. report this as an SAE to the sponsor and IRBC. call the sponsor and ask for clarification on whether this is an SAED. document the emergency in the CRF, but it’s not necessary to contact the sponsor or IRB B. report this as an SAE to the sponsor and IRB(there is no absolute cutoff time when an event is not reportable. Chronic effects can be seen long after participation in a trial)
During a site’s closeout visit the CRA notices an SAE hasn’t been reported to the IRB. The IRB close-out report has been completed and filed. Which of the following actions should the CRC take FIRST?A. inform the IRB in writing of the SAE and request written confirmation of the notification and any responseB. Call the IRB to notify them of the SAE and assure written communication will followC. Assure the PI notifies the IRB of the SAE and request written confirmation of notification and any responseD. notify the PI of the CRA’s findings and request that he assess the event D. notify the PI of the CRA’s findings and request that he assess the event(PI always consulted first to verify accuracy of event. PI assigns severity, relationship. If SAE, should then be reported to sponsor and then IRB)
Following a study closeout, a subject reports an end time for an on-going AE. The best way for a CRC to note this information would be to A. record the stop time on the sourceB. report the stop time to the sponsor by phoneC. complete a data clarification form and forward to the sponsorD. contact the FDA within 7 working days C. complete a data clarification form and forward to the sponsor(need a paper trail; PI has already signed off on all CRFs, so requesting a clarification form helps)
When interviewing a subject at a routine follow-up visit for a cardiovascular trial, the CRC discovers the subject was hospitalized with chest pain while on vacation. The CRC should:A. report to the sponsor after obtaining more info from the hospitalB. report this event to the sponsor immediately with the information availableC. confer with the PI for an assessment prior to notifying the sponsorD. record the AE of chest pain and remind the patient to report such events promptly B. report this event to the sponsor immediately with the information available(hospitalization meets reporting criteria, which requires prompt reporting of AEs to the sponsor
Which of the following documents must be signed and dated by a PI prior to enrolling subjects in a device study?A. current CVB. FDA form 1572C. FDA form 3500AD. statement of investigator commitment D. statement of investigator commitment (FDA form 1572 is specific for drug trials
Calculate the number of boxes of IP needed to be ordered to complete a 24 week trial for 6 subjects. Each box contains 8 vials. Three subjects use 1 vial per week, and 3 subjects use 2 vials per week.A. 9 boxesB. 15 boxesC. 21 boxesD. 27 boxes D. 27 boxes(3+6 = 9 vials/week. 9 x 24 = 216. 216/8 = 27)
A subject screens for a new study 30 days after completing the final visit of a 2-year double-blind study. Previous semiannual eye exams were normal. An eye exam done at this screening visit reveals a cataract in the right eye. The CRC should:A. inform the IRB of the AEB. inform the sponsor of the original studyC. request the previous sponsor break the blindD. document in the previous study’s medical hx page B. inform the sponsor of the original study
A CRCs site has been participating in a study comparing a new cholesterol lowering drug to an existing brand. The CRC has recently received notice of an upcoming FDA audit. Which of the following is the MOST likely reason for the audit?A. the IP is supporting claims of a new application for an existing drugB. this was a random selection since the site was one of top 5 enrolling sitesC. this study is pivotal to the NDA approval and the investigator at this site has 10 other ongoing studiesD. the sponsor has submitted an abbreviated NDA A. the IP is supporting claims of a new application for an existing drug
A monitor is under strict and sudden deadlines and must visit the site in 4 days. Her requests for med records and other docs are extensive. The CRC has back to back visits that day. The CRC should1. inform the monitor that prep for the visit is needed and the site requires at least 1 week’s notice2. contact med rec department etc. to obtain subject charts and arrange for monitoring space.3. ask monitor if there is another day within the week that could accommodate her needs while still allowing for subject visits4. reschedule first and las visit of requested day if possible within window, to allow some time with the monitor A. 1, 2 and 3B. 1, 2 and 4C. 1, 3 and 4D. 2, 3, and 4 D. 2, 3, and 4
“A CRC for a trial on varicose veins includes notes on the bottom of invoices sent from his office that reads “”please call our office to receive new treatments for spider varicose veins””. Which of the following is true:A. this is acceptable and does not require IRB approvalB. this is acceptable, but it requires IRB approvalC. this is acceptable if responding patients are immediately informed of the trial detailsD. this is not an acceptable statement or form of advertising” D. this is not an acceptable statement or form of advertising (IRB must review/approve — this doesn’t indicate research)
According to the CFR, who else must sign the ICF in addition to the subject?A. the person obtaining consentB. the PIC. the PI and person obtaining consentD. no one else D. no one else (FDA requires only the subject to sign)
Which of the following are required elements of the ICF?1. contact info for additional info about the research2. disclosure of alternative procedures or treatment, if any, that may be beneficial to patient3. payment disclosure of PI, if applicable4. number of investigators completing the studyA. 1 and 2B. 1 and 4C. 2 and 3D. 3 and 4 A. 1 and 2(PI payment is not required, nor is # of investigators)
The ICF is designed to give the subject or LAR easy to understand information regarding which of the following aspects of the study?A. cost to the study siteB. alternative therapies for all studiesC. general design and rational for studyD. penalties subjects may encounter if they withdraw B. alternative therapies for all studies
By signing the ICF, the subject or LAR is agreeing that:1. all info on ICF is correct2. consent was freely given3. the subject will not withdraw from the study4. the subject’s medical records may be accessedA. 1 and 2B. 1 and 3C. 2 and 4D. 3 and 4 C. 2 and 4
A physician orders a CBC as SOC, but will need to obtain additional lab tests to determine the patient’s eligibility for a study. Which of the following items is the MOST important to record in the patient’s chart?A. patient agrees to pay for additional tests if they are rejected by his insuranceB. time and date ICF was signedC. patient understands why they’re having the chemistry panel doneD. staff gave patient the choice to have the chemistry panel done B. time and date ICF was signed(SOC is fine, but additional tests to determine eligibility can only be done after subject signs ICF
A subject wants to schedule a visit for 11:30am. This visit requires a PE by an MD, a blood draw, and vitals. The MD will be out from 11:30-12:00. How long can your subject expect to spend on the visit?A. 1/2 hourB. 1 hourC. 1.5 hoursD. 2 hours A. 1/2 hour(assuming other procedures can be done prior to MD’s arrival, they will be waiting at least 30 mins)
According to the protocol, a patient is to return after the procedure for a 30-day visit, +/- 3 days, for a PE by the PI. A subject is consented April 20th, and the procedure is done on April 22nd. After the procedure, the subject informs the CRC he can only return for the follow-up before May 6 or after May 28th. What should the CRC do?1. continue the protocol as planned2. notify the IRB3. Schedule the termination visit ASAP4. document and contact the study monitor A. 1 and 2B. 1 and 4C. 2 and 3D. 3 and 4 D. 3 and 4the window doesn’t allow for the procedure
Subject is in for a screening visit and lab draw (CBC). He has a visit with his PCP to have his glucose checked. After the subject states it is difficult to get blood from his arm, the CRC gets it on the first try. The subject says he wants his glucose checked too. What is the MOST appropriate action for the CRC?A. collect an EDTA tubeB. collect an SSTC. collect an EDTA and SSTD. collect an EDTA and plain red top A. collect an EDTA tube(EDTA used for most hematology labs, including the chem panel. the CRC must only collect what is required per protocol, and nothing more)
The HIPAA Privacy Rule applies to all except:A. PHIB. psychotherapy trialsC. research resultsD. materials used for the purpose of developing a protocol D. materials used for the purpose of developing a protocol
A CRC is on a Phase II study on a new cardiac device. The sponsor is using a remote data entry system for the CRF entries which requires data to be entered electronically. Each CRC is provided a secure login and password. One of the CRCs shares her password with study staff. Which of the following is the BEST sequence of actions for the lead CRC to take?1. recommend the PI discipline the CRC2. Request new passwords for the CRC3. report the problem to the PI and follow instructions4. discuss with the CRC why this is not acceptable GCPA. 1, 2, 3 4B. 2, 4, 3, 1C. 3, 1, 2, 4D. 4, 3, 2, 1 B. 2, 4, 3, 1
The CRC finds out a study subject is hospitalized with a CVA. According to ICF guidelines, how soon must he IRB receive notification of this info?A. 1 dayB. 7 daysC. 15 daysD. promptly, no time specified D. promptly, no time specified SAEs should be promptly reported to the IRB
The FDA’s acceptance of data from trials for decision-making purposes is dependent on it’s ability to verify the quality and integrity of data. Which of the following is true re: the use of electronic systems to collect and store data at sites?A. when original observations are entered directly into an electronic system, the electronic record is not considered sourceB. it is unnecessary to retain original or certified copies of all source docs when an electronic system is usedC. security measures should be in place to prevent unauthorized access to data and to the systemD. for multiple users at one site, it is acceptable for staff to share and work under one password C. security measures should be in place to prevent unauthorized access to data and to the system
A CRC is monitoring an IND study. All IND safety letters from the sponsor are at the site. There isn’t any documentation that the IND safety letters were sent to the IRB. What is the CRC’s next step?A. no action is requiredB. ensure the CRA implements an IND safety letter tracking logC. report the findings in the reportD. instruct/review with the site that letters need to be forwarded to the IRB D. instruct/review with the site that letters need to be forwarded to the IRB
The financial aspects of a clinical trial mutually agreed upon by the sponsor and PI should be stated in the A. financial disclosure statement and signed at the pre-study meetingB. itemized budget and signed at the pre-study meetingC. contract and signed prior to the shipping of IPD. confidentiality statement and signed prior to study initiation C. contract and signed prior to the shipping of IP
An adverse drug experience not initially determined to be reportable is later determined to be a reportable occurrence. The sponsor should report this eventA. by phone within 7 working daysB. in a written report within 7 calendar daysC. in a written report within 15 calendar daysD. by phone within 24 hours C. in a written report within 15 calendar days
Which of the following is an example of how the Principle of Beneficence can be applied to a study using human subjects?A. Determining the study has maximized benefits and minimized risksB. Enrolling a diverse group of participantsC. Allowing patients to withdraw at any time A. Determining the study has maximized benefits and minimized risks
The World Medical Association (WMA) ethical principles for medical research involving human subjects is called:A. The National Research ActB. The Declaration of HelsinkiC. The Belmont ReportD. The International Research Act B. The Declaration of Helsinki
Informed consent documents must include the followingA. A statement that study involves researchB. A statement of possible riskC. A discussion of possible alternative treatments D. All of the above D. All of the above
The responsibility of the participant’s safety lies withA. the sponsorB. the PIC. the IRB B. the PI
“Which of the following statements best defines the term “”efficacy”” in a clinical trial?A. the best possible outcome of a clinical trialB. a determination proving there is a statistically significant difference in the pK effect of the study drug vs. placeboC. the capacity of a drug or treatment to produce beneficial effects on the course of action or duration of a disease” C. the capacity of a drug or treatment to produce beneficial effects on the course of action or duration of a disease (does the drug do what it’s supposed to do?)
The short form embodies all of the elements of ICF as required under 21 CFR 50.25A. TrueB. False B. False
When a short form is used for Informed Consent, the witness must sign either the short form or the summaryA. trueB. false B. false (witness must sign both the short form and the summary)
One of the primary purposes of a Phase II study is to:A. demonstrate long-term safety and efficacyB. gather information on additional indications for the drugC. demonstrate efficacy within the established dose rangeD. familiarize physicians with the drug C. demonstrate efficacy within the established dose range
Where can one find a complete list of expected side effects (expected AEs)?A. protocolB. IBC. 1572 B. IB
The two main aspects of a study that will be looked at by the FDA during an audit are:A. study conduct and study dataB. study conduct and recruitment methodologyC. study data and statistical methodologyD. drug storage conditions and pharmacy records A. study conduct and study data