ACRP CCRC Exam Review (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A
ACRP CCRC Exam Review (Latest 2024/
2025 Update) Questions and Verified
Answers| 100% Correct| Grade A
Q: When is an AE considered an ADR?
Answer:
In pre-approved clinical settings
- Either a new med product OR existing med product with new usages
- Must be causal relationship
In post-marketed products - noxious & unintended response to a drug that occurs at normal doses
Q: What is an unexpected ADR?
Answer:
ADR that is not consistent in nature and/or severity with IB
Q: What situations require expedited reporting to IRB?
Answer: - Any UNEXPECTED SERIOUS ADR
- Increased rate of occurrence of EXPECTED SERIOUS ADR
- Significant hazard to patient population (e.g. lack of efficacy of IP treating a life-threatening
disease) - Major safety finding from new animal study
Q: Expedited Reporting
When should you report fatal/life-threatening UNEXPECTED ADRs?
Answer:
ASAP (no later than 7 calendar days)
Complete full report no later than 8 days after that
Q: Expedited Reporting
When should you report non-fatal/life-threatening UNEXPECTED ADRs?
Answer:
ASAP (no later than 15 calendar days)
Q: What data should be included in an expedited report?
Answer:
- patient info (study #, DOB, sex, etc.)
- suspected med. products (brand, batch #, dosage form, indication, route of admin, etc.)
- other treatment/therapies
- details of event (outcome, setting, start/stop dates, etc.)
- contact info of reporter
- admin/sponsor info & contact
Q: When should blind be broken?
Answer:
Only if treatment assignment is necessary for participant’s care
Q: When should any intentional or unintentional breaking of blind be reported?
Answer:
At end of trial
Q: If an SAE is deemed necessary for expediting reporting, should the blind be broken?
Answer:
Yes–at least by the sponsor, if not the PI too
Q: In what circumstance would an SAE not require breaking the blind?
Answer:
Trials with a fatal or “serious” outcome as the primary endpoint (usually the SAE is attributed to
the disease, so no need to report it as an ADR or unblind the participant)
Q: Do events that occur post-study fall under the same expedited reporting requirements?
Answer:
A Causality Assessment & Determination of Expectedness are needed for a decision about
whether expedited reporting is required
Q: What are the required components of an IRB?
Answer:
- at least 5 members
- at least 1 who is non-scientific
- at least 1 who is independent of the institute/site
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“Who is considered “”vulnerable””?” 1. prisoners2. med/nursing students3. military4. people in nursing homes5. impoverished/unemployed/homeless6. minors7. ethnic minorities8. people with incurable/terminal illnesses
A participant develops colon cancer (unrelated to study) and is asymptomatic. This is considered an SAE because colon cancer is life-threatening. True or False? FALSE
Who is responsible for designing the protocol? a) PI b) Sponsor c) Institution d) IRB/IEC b) Sponsor
You’re a study manager & one of your monitors reports significant non-compliance at a site. Which is your first course of action?a) 2nd opinion monitor visit b) study report c) root cause analysisd) suspension of trial c) root cause analysis
If attempts to secure compliance at a site have failed, should sponsor…a) terminate the siteb) re-train the site & develop a corrective plan a) terminate the site
“What is “”Phase IV”” also known as?” Therapeutic Use
What are ways to minimize the amount of blood drawn and/or number of venipunctures from pediatric patients? -use sensitive assays (to reduce the amt of blood req.)-use labs that are used to handling small volumes of blood to perform analyses-collect routine bloodwork at the same time as PK whenever possible-indwelling catheters-sparse sampling-modeling adult data for pharmacokinetics
Pharmacokinetic Phase I studies in children are generally conducted in healthy pediatric subjects. True or False? FALSE
What is the name of the assessment used to stage a youth’s pubertal development? Tanner Staging
When is an AE considered an ADR? In pre-approved clinical settings1. Either a new med product OR existing med product with new usages2. Must be causal relationshipIn post-marketed products1. noxious & unintended response to a drug that occurs at normal doses
What is an unexpected ADR? ADR that is not consistent in nature and/or severity with IB
What situations require expedited reporting to IRB? 1. Any UNEXPECTED SERIOUS ADR2. Increased rate of occurrence of EXPECTED SERIOUS ADR3. Significant hazard to patient population (e.g. lack of efficacy of IP treating a life-threatening disease)4. Major safety finding from new animal study
Expedited ReportingWhen should you report fatal/life-threatening UNEXPECTED ADRs? ASAP (no later than 7 calendar days)Complete full report no later than 8 days after that
Expedited ReportingWhen should you report non-fatal/life-threatening UNEXPECTED ADRs? ASAP (no later than 15 calendar days)
What data should be included in an expedited report? 1. patient info (study #, DOB, sex, etc.)2. suspected med. products (brand, batch #, dosage form, indication, route of admin, etc.)3. other treatment/therapies4. details of event (outcome, setting, start/stop dates, etc.)5. contact info of reporter6. admin/sponsor info & contact
When should blind be broken? Only if treatment assignment is necessary for participant’s care
When should any intentional or unintentional breaking of blind be reported? At end of trial
If an SAE is deemed necessary for expediting reporting, should the blind be broken? Yes–at least by the sponsor, if not the PI too
In what circumstance would an SAE not require breaking the blind? “Trials with a fatal or “”serious”” outcome as the primary endpoint (usually the SAE is attributed to the disease, so no need to report it as an ADR or unblind the participant)”
Do events that occur post-study fall under the same expedited reporting requirements? A Causality Assessment & Determination of Expectedness are needed for a decision about whether expedited reporting is required
What are the required components of an IRB? 1. at least 5 members2. at least 1 who is non-scientific3. at least 1 who is independent of the institute/site
“True or False: Only “”independent”” IRB members can cast a vote.” TRUE
When can an investigator deviate from the protocol WITHOUT IRB approval to do so? 1. immediate hazard to trial subjects needs to be eliminated2. only admin. changes (like phone #’s)***Ultimately these changes will still need to be submitted to IRB at some point
What should you do if you need to make changes to information entered in a CRF? 1. insert an explanation for the change2. date & initial the change3. do not obscure the original entry (e.g. should have just one line through–NOT blacked out, deleted, etc.)
How long should essential documents be retained after study completion? 2 years
How long do IRBs hold records? 3 years
Which SAEs should be reported to SPONSOR & when should they be reported? ALL SAEs reported IMMEDIATELY(unless the IB/protocol deemed the specific SAE as unnecessary to report)
True or False: The investigator cannot supply IRB and Sponsor with private information from a deceased participant, such as medical death reports and autopsy results. FALSE. The investigator SHOULD provide these if either entity asks for these additional documents
Which entity(ies) have the ability to terminate/suspend the trial? 1. IRB2. Sponsor3. Investigator (at their site only)
Sponsor’s Quality Management using Risk-Based Approach1. Critical Process & Data Identification -during protocol development-ensure participant protection-ensure reliability of results
Sponsor’s Quality Management using Risk-Based Approach2. Risk Identification Identify risks at 2 levels:-system level (SOPs, personnel, software, etc.)-clinical trial level (design, data collection, ICFs, etc.)
Sponsor’s Quality Management using Risk-Based Approach3. Risk Evaluation Evaluate:-likelihood of errors-extent that errors would be detectable-impact of errors on pt. protection & reliability of results
Sponsor’s Quality Management using Risk-Based Approach4. Risk Control -decide which risks to try to reduce and/or just accept-establish pre-defined quality tolerance (based on medical & statistical characteristics of variables)
Sponsor’s Quality Management using Risk-Based Approach5. Risk Communication -document everything-inform risk control plan to all parties involved
Sponsor’s Quality Management using Risk-Based Approach6. Risk Review -periodically assess the risk control plan
Sponsor’s Quality Management using Risk-Based Approach7. Risk Reporting -summarize the quality management approach in the CSR
Review of accumulating data from centralized monitoring can be used to: 1. identify missing/inconsistent data & protocol deviations2. examine data trends within & across sites3. evaluate for errors in data collection or reporting4. analyze site characteristics/performance5. select sites needing on-site monitoring
“What information should be included in the protocol under “”subject withdrawal criteria””?” 1. when & how to withdraw pts from trial OR IP2. type & timing of data to collect from withdrawn pts3. whether & how they’ll be replaced4. follow-up plan for pts withdrawn from an IP
How often should the IB be reviewed? Annually (and revised if necessary)
What to include in the IB? 1. Title page w/ version #2. Confidentiality Statement3. TOC4. Brief Summary5. Introduction (ingredients, class, indication, etc.)6. Properties/Formulation (chem/phys/pharm, storage & handling, similarities to other compounds)7. non-clinical studies-non clinical pharmacology-pharmacokinetics & product metabolism (absorption)-toxicology in animals8. effects in humans (PK & product metabolism)9. safety & efficacy studies10. marketing experience
What type of variable determines the sample size? primary variable
What is a composite variable & what is an example of one? “-combo of mult. measurements into ONE variable-ex: using multiple psychiatric scales to assess presence of variable, “”bipolar disorder”””
What is a global assessment variable and what is the concern with them? -measure OVERALL safety, efficacy, usefulness-can be subjective, but if it’s a primary/secondary it should have a concrete definition
When would multiple primary variables be used? -to determine the extent of intercorrelation -need to know to avoid Type I errors
Type I vs. Type II error Type I = false positive (incorrectly rejects the null)Type II = false negative (incorrectly fails to reject null)
What is a surrogate variable & when would you use them? -an indirect measure of a variable-when observing the actual clinical effect is not practical/feasible
What are 2 concerns with surrogate variables? (give examples) 1. may not be a true predictor of outcome of interest-ex: may measure specif. activity of just ONE pharmacol. mechanism but not others and/or the ultimate clinical effects of drug-ex: treatment may show positive effects on the surrogate but is ultimately detrimental to patient outcome (or vice versa)2. may not yield quantitive measure of clinical benefit that can be weighed against AEs
What are some ways in which categorized variables can be useful? “-can categorize continuous & ordinal variables if needed-precise criteria should be defined to be considered “”successful”” or “”beneficial”” (ex: using % improved relative to baseline, ranking on diagnostic scales, etc.)”
“What are the advantages of “”block randomization”” ?” 1. incr. comparability of tx groups2. better guarantee tx groups will be close in size3. crossover trials: obtained balanced designs with greater efficiency & easier interpretation
How many variables is too many to stratify by? 2-3 stratified factors
What are 2 major problems with crossover designs? 1. residual influence of past tx in subsequent tx periods2. difficult to assign AEs to the right tx group
What are 2 functions of a factorial design? 1. assess interactions b/w 2 treatments2. establish dose-response relationships
What are the objectives of dose-response trials? 1. confirm efficacy2. investigate shape & location of dose-response curve3. estim. appropriate starting dose4. identify strategies for indiv. dose adjustments5. determ. max dose (beyond which additional benefit is unlikely)
What are 2 purposes of Group Sequential Designs? 1. facilitate conduct of interim analysis2. determ. if the study should be terminated early
When should eligibility criteria be changed? 1. when new med. knowledge becomes available2. if regular screen fails occur due to a particular criterion
Can interim analysis be done even if it’s not at the specified time in the protocol? Yes, but protocol amendment should be made prior to unblinded access to tx comparison data
What are circumstances where randomized participants may be excluded from full analysis set? 1. eligibility violation2. failure to take at least 1 dose of IP3. lack of any data post-randomization
Subjects who failed to satisfy a particular eligibility criterion may be excluded from analysis w/o introducing bias IF: 1. entry criterion was measured prior to randomization2. detection of eligibility violations can be made objectively3. all subjects receive same scrutiny for violations4. all detected violations for the same criterion are excluded
“What is a “”per-protocol analysis set””?” only analyze subset of subjects who are more compliant with protocol
What is a Bayesian Approach to data analysis? -provides posterior probability distribution for a parameter (e.g. treatment effect)-derived from observed data & prior probability distribution for the parameter
What is content validity? Extent to which a variable measures what it’s supposed to measure
Inter-rater Reliability vs. Intra-rater Reliability Inter-rater: property of yielding equivalent results when used by DIFFERENT raters on different occasionsIntra-rater: property of yielding equivalent results when used by SAME rater on different occasions
Features to consider in research of preterm infants: -gestational age @ birth & age after birth-immaturity of renal & hepatic clearance mechs.-protein binding & displacement issues-penetration of IP into CNS-unique neonatal disease states-unique susceptibilities of preterm newborns-rapid & variable maturation of all physiologic processes-transdermal absorption of IP
What are study design issues in studies of preterm infants? -weight & age-small blood volumes-small number of patients per care center-difficulties in assessing outcomes
Features to consider in research of infants specifically (vs. older children) -blood brain barrier not fully mature-oral absorption of med products is less predictable until toddler age-doses may need to be adjusted due to maturation of renal & hepatic clearance mechs & diff body water/fat content-incr. susceptibility to toxic effects
Features to consider in research of children (2-11) -onset of puberty is highly variable
Features to consider of adolescents (12+) -sexual maturation (meds interfering w/ sex hormones & need for contraception and preg testing)-hormonal changes-noncompliance-recreational use of non-prescribed drugs
Which of the following describes an adequate, well-controlled trial?a) Trial is closely monitoredb) IP meets GMP standardsc) Effects of IP can be assessedd) Source documentation is verified for all subjects c) effects of IP can be assessed
When choosing a CRO to manage a clinical trial, which of the following are required by ICH Guidelines? 1. Transfer of responsibilities must be documented in writing 2. Responsibilities transferred to the CRO become the ultimate responsibility of the CRO. 3. A sponsor must transfer all of the responsibilities to one CRO. 4. Obligations not described in any written agreement shall be deemed not to have transferred.a) 1 and 3 onlyb) 1 and 4 onlyc) 2 and 3 only d) 2 and 4 only b) 1 and 4 only
True or False: According to ICH guidelines, a sponsor should only transfer responsibilities to one CRO FALSE
The BEST recommendation for a potential investigator in a Phase III diabetic clinical trial is a physician who has 1. a private practice with a limited patient base 2. high interest, but little time for clinical trials 3. applied for board cert in endocrinology 4. received an inspection report 6 years ago citing missing SOPsa) 1 and 2 onlyb) 1 and 3 onlyc) 2 and 4 onlyd) 3 and 4 only d) 3 and 4 only
Schedule of monitoring visits is determined by the 1. ICH guidelines 2. regulatory submission guidelines 3. protocol complexity 4. rate of enrollmenta) 1 and 2 onlyb) 1 and 3 onlyc) 2 and 4 onlyd) 3 and 4 only d) 3 and 4 only
True or False: IMs are required by the regulatory authority FALSE
After arriving for an initiation visit, the CRA realizes the IP has not been shipped. Which of the following should the CRA have done to ensure proper shipment? 1. verified the status of the shipment with clinical supply. 2. ensured that all critical documents were processed. 3. assured that the manufacturing was on schedule. 4. confirmed the clinic’s address for shipping clinical suppliesa) 1, 2, and 3 onlyb) 1, 2, and 4 onlyc) 1, 3, and 4 onlyd) 2, 3, and 4 only b) 1, 2, and 4 only
When scheduling an initiation visit, the CRA is told that the PI does not participate in IVs. However, the CRC, pharmacist, & lab director are available. Which of the following is the CRA’s BEST course of action? a) recommend the PI appoint a sub-I to attend the IVb) meet with the CRC and ask that she relay the pertinent info to the PIc) proceed with the visit as scheduled since the other participants are availabled) request that senior management reinforce trial participation responsibilities with the PI d) request that senior management reinforce trial participation responsibilities with the PI
What is a positive re-challenge? If a participant has a suspected reaction to a drug, you stop the IP to see if the reaction also stops, and if it does, you start the drug again to see if the reaction returns
While reviewing data listings, a CRA notices a missing resolution date for an AE of sepsis for which the subject was hospitalized. After confirming that the date was not recorded on the AE page of the CRF, which of the following would the CRA consult next to find the missing info? a) SAE report formb) copy of blood culture resultsc) concomitant medication page of the CRFd) laboratory hematology results page of the CRF a) SAE report form
A CRA is informed by a site that a trial subject called the site complaining of a general itchy rash all over her body. The PI has assessed the subject and administered a prohibited medication. Which of the following actions should the CRA recommend for the site? 1. Update the CRF 2. Report this information to the IRB3. Notify the regulatory authority 4. Instruct the subject to stop taking the prohibited medicationa) 1 and 2 onlyb) 1 and 4 onlyc) 2 and 3 onlyd) 3 and 4 only a) 1 and 2 only
Which of the following is considered to be an SAE?a) skin cancerb) transient hypotensionc) treatment at an urgent care center d) a congenital anomaly in a male subject’s offspring d) congenital abnormality
“For SAEs, how is “”life-threatening”” defined?” pt was at risk of death DURING THE EVENT (not eventually cause death, not if it would hypothetically cause death, & not if it could cause death later)
True or False: Anything not transferred over to CRO in writing is the responsibility of the Sponsor TRUE
What are examples of human pharmacology studies? 1. drug tolerance studies2. drug interaction studies3. PKs and PDs studies
What phase are most human pharmacology studies? Phase I
What is Phase III also known as? Therapeutic confirmatory
What is Phase II also known as? Therapeutic exploratory
What is Phase I also known as? Human pharmacology
What is an excipient? An inactive substance that serves as a vehicle or medium for a drug or other active substance
What are the 3 principles of the Belmont Report? 1. Respect for persons2. Beneficence3. Justice
How long does the FDA have to review an IND? 30 days
True or False: Conmeds do not need to be included in the SAE report. FALSE
What is the difference between pharmacokinetics and pharmacodynamics? PK: movement of drug within the bodyPD: how the drug affects the organism
The IRB can waive the requirement for assent (in children) if it determines: 1. children are incapable of understanding the research2. There’s a prospect of direct benefit to the children that is not available outside of the research
What are 3 types of comparison trials? 1. trials to show superiority2. trials to show equivalence/non-inferiority3. trials to show dose-response relationship
How many days does a sponsor have to report an emergency use of an IP to the FDA? 5 working days
What are the two things NDA stands for in clinical research? 1. Non-disclosure Agreement2. New Drug Application (for FDA)
When is an impartial witness used? When a participant’s LAR is not able to read
Who conducts an inspection & where can it be conducted? 1. Regulatory authorities2. At sites, at CRO, at Sponsor, etc.
When is a monitoring report created/sent? After EACH site visit (can be pre-trial, during, after, etc.)
Who implements an audit?a) Regulatory authoritiesb) Monitor/CRAc) Sponsord) IRB/IEC c) Sponsor
True or False: When conducting an audit, the sponsor will appoint representatives from their institution to complete the audit. FALSE: They will appoint independent auditors to run the audit
How should the essential documents be grouped? By stage of trial (pre-trial, during trial, post-trial)
What are the purposes of Phase I studies? 1. Estimate initial safety/tolerability in humans2. Pharmacokinetics (PK)-drug absorption, metabolism, excretion-e.g. oral drugs: look at how food interacts with it-e.g. look at clearance of drug from body3. Pharmacodynamics (PD)-drug blood levels to response-may guide the dosage/dose regimen for future studies-can be conducted in people with or w/o disease4. Early measurement of drug activity-usually measured in later phases but sometimes able to measure in Phase I if activity can be seen after just a short duration
True or False: Pharmacokinetic (PK) studies are only conducted in Phase I trials FALSE: usually conducted in Phase I but can be measured in other phases too
True or False: Pharmacodynamics (PD) can be studied in people with AND without the disease of interest TRUE
What are the purposes & characteristics of Phase II studies? 1. Explore therapeutic efficacy2. Determine dose (to be used in Phase III)-early studies: dose-escalation design to give estimate of dose-response-later studies: parallel dose-response design to confirm dose-response (sometimes done in Phase III)3. Target populations (mild vs. severe disease)4. Narrow eligibility criteria (leads to a more homogenous population)
True or False: Doses used in Phase II trials are USUALLY less than the highest dose used in Phase I trials. TRUE
What are the purposes/characteristics of Phase III trials? 1. Confirm evidence from Phase II that drug is safe and efficacious 2. MAY also explore:-efficacy in combo with another drug-drug’s efficacy in different disease stages-safety of long-term use/exposure of drugs for chronic conditions3. Wider more heterogenous participant population
What are the purposes/characteristics of Phase IV trials? 1. After drug approval by regulatory authorities2. Studies not necessary for approval, but important for optimizing the drug’s use3. Examples of study types:-epidemiological-mortality/morbidity -drug interactions
Dose Escalation Designs vs Parallel Dose-Response Designs DOSE ESCALATION-increase dose until max tolerated dose-measure dose-related toxicity PARALLEL DOSE-RESPONSE-several fixed dose groups (usually randomized)-usually a placebo group-either titrated up to assigned dose or start immediately-gives you a mean dose-response for population (not the curve though)-often factorial study design
What happens if there are drug reactions to the placebo or active comparator drug? -Sponsor’s decision on whether to report to regulatory authorities and/or manufacturer-Usually do not satisfy the criteria for expedited reporting
“Scenario: A participant experiences an ADR. When you refer to the IB, you notice the particular ADR is only “”expected”” for the drug when it is used in a different dosage/formulation/route/indication/etc. Should you expedite the report to IRB or not report it since there is evidence in the IB that this kind of ADR is to be expected in other situations?” Err on the side of over-reporting than under-reporting. Do the expedited report since the ADR is not expected in THIS particular situation
Scenario: You are the sponsor for a study that is not closed. An Investigator from that study just submitted a report of a new SAE that occurred in one of their participants (post-study). As the sponsor, what should you do? Assess the need for expedited reporting as if it occurred during the study
What are the minimum criteria to include for expedited reporting? 1. An identifiable participant2. A suspect IP3. An identifiable reporting source4. An event/outcome that is both SERIOUS and UNEXPECTED (and there is suspected causal relationship)
How is an ADR determined to be either expected or unexpected? “1. IB2. Reports that add significant info on already known ADRs (helps you determine if the ADR you witness is more severe/frequent than usual, making it “”unexpected””)”
In diseases that also affect adults, testing a medicinal product would not begin in the pediatric population until what phase? Phase II or III
What does API stand for? Active Pharmaceutical Ingredient