ACRP CCRC Exam Review (NEW 2024/ 2025 Update) Questions and Verified Answers, Exams of Law

Download ACRP CCRC Exam Review (NEW 2024/ 2025 Update) Questions and Verified Answers and more Exams Law in PDF only on Docsity! ACRP CCRC Exam Review (NEW 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A QUESTION What should you do if you need to make changes to information entered in a CRF? Answer: 1. insert an explanation for the change 2. date & initial the change 3. do not obscure the original entry (e.g. should have just one line through--NOT blacked out, deleted, etc.) QUESTION How long should essential documents be retained after study completion? Answer: 2 years QUESTION How long do IRBs hold records? Answer: 3 years QUESTION Which SAEs should be reported to SPONSOR & when should they be reported? Answer: ALL SAEs reported IMMEDIATELY (unless the IB/protocol deemed the specific SAE as unnecessary to report) QUESTION 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. Answer: FALSE. The investigator SHOULD provide these if either entity asks for these additional documents QUESTION Which entity(ies) have the ability to terminate/suspend the trial? Answer: 1. IRB 2. Sponsor 3. Investigator (at their site only) QUESTION Sponsor's Quality Management using Risk-Based Approach 1. Critical Process & Data Identification Answer: -during protocol development -ensure participant protection -ensure reliability of results QUESTION Sponsor's Quality Management using Risk-Based Approach 2. Risk Identification 4. follow-up plan for pts withdrawn from an IP QUESTION How often should the IB be reviewed? Answer: Annually (and revised if necessary) QUESTION What to include in the IB? Answer: 1. Title page w/ version # 2. Confidentiality Statement 3. TOC 4. Brief Summary 5. 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 animals 8. effects in humans (PK & product metabolism) 9. safety & efficacy studies 10. marketing experience QUESTION What type of variable determines the sample size? Answer: primary variable QUESTION What is a composite variable & what is an example of one? Answer: -combo of mult. measurements into ONE variable -ex: using multiple psychiatric scales to assess presence of variable, "bipolar disorder" QUESTION What is a global assessment variable and what is the concern with them? Answer: -measure OVERALL safety, efficacy, usefulness -can be subjective, but if it's a primary/secondary it should have a concrete definition QUESTION When would multiple primary variables be used? Answer: -to determine the extent of intercorrelation -need to know to avoid Type I errors QUESTION Type I vs. Type II error Answer: Type I = false positive (incorrectly rejects the null) Type II = false negative (incorrectly fails to reject null) QUESTION What is a surrogate variable & when would you use them? Answer: -an indirect measure of a variable -when observing the actual clinical effect is not practical/feasible QUESTION What are 2 concerns with surrogate variables? (give examples) Answer: 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 QUESTION What are some ways in which categorized variables can be useful? Answer: -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.) QUESTION When is an AE considered an ADR? Answer: In pre-approved clinical settings 1. Either a new med product OR existing med product with new usages 2. Must be causal relationship QUESTION 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 QUESTION 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) QUESTION 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 QUESTION What are the required components of an IRB? Answer: 1. at least 5 members 2. at least 1 who is non-scientific 3. at least 1 who is independent of the institute/site QUESTION True or False: Only "independent" IRB members can cast a vote. Answer: TRUE QUESTION When can an investigator deviate from the protocol WITHOUT IRB approval to do so? Answer: 1. immediate hazard to trial subjects needs to be eliminated 2. only admin. changes (like phone #'s) ***Ultimately these changes will still need to be submitted to IRB at some point QUESTION What are the advantages of "block randomization" ? Answer: 1. incr. comparability of tx groups 2. better guarantee tx groups will be close in size 3. crossover trials: obtained balanced designs with greater efficiency & easier interpretation QUESTION How many variables is too many to stratify by? Answer: 2-3 stratified factors QUESTION What are 2 major problems with crossover designs? Answer: 1. residual influence of past tx in subsequent tx periods 2. difficult to assign AEs to the right tx group QUESTION What are 2 functions of a factorial design? Answer: 1. assess interactions b/w 2 treatments 2. establish dose-response relationships QUESTION What are the objectives of dose-response trials? Answer: 1. confirm efficacy 2. investigate shape & location of dose-response curve 3. estim. appropriate starting dose 4. identify strategies for indiv. dose adjustments 5. determ. max dose (beyond which additional benefit is unlikely) QUESTION What are 2 purposes of Group Sequential Designs? Answer: 1. facilitate conduct of interim analysis 2. determ. if the study should be terminated early QUESTION When should eligibility criteria be changed? Answer: 1. when new med. knowledge becomes available 2. if regular screen fails occur due to a particular criterion QUESTION What are study design issues in studies of preterm infants? Answer: -weight & age -small blood volumes -small number of patients per care center -difficulties in assessing outcomes QUESTION Features to consider in research of infants specifically (vs. older children) Answer: -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 QUESTION Features to consider in research of children (2-11) Answer: -onset of puberty is highly variable QUESTION Features to consider of adolescents (12+) Answer: -sexual maturation (meds interfering w/ sex hormones & need for contraception and preg testing) -hormonal changes -noncompliance -recreational use of non-prescribed drugs QUESTION Which of the following describes an adequate, well-controlled trial? a) Trial is closely monitored b) IP meets GMP standards c) Effects of IP can be assessed d) Source documentation is verified for all subjects Answer: c) effects of IP can be assessed QUESTION 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 only b) 1 and 4 only c) 2 and 3 only d) 2 and 4 only Answer: b) 1 and 4 only QUESTION True or False: According to ICH guidelines, a sponsor should only transfer responsibilities to one CRO Answer: FALSE QUESTION 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 SOPs a) 1 and 2 only b) 1 and 3 only c) 2 and 4 only d) 3 and 4 only Answer: d) 3 and 4 only QUESTION Schedule of monitoring visits is determined by the 1. ICH guidelines 2. regulatory submission guidelines 3. protocol complexity 4. rate of enrollment a) 1 and 2 only b) 1 and 3 only c) 2 and 4 only d) 3 and 4 only Answer: d) 3 and 4 only QUESTION True or False: IMs are required by the regulatory authority Answer: FALSE QUESTION 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 supplies QUESTION True or False: Anything not transferred over to CRO in writing is the responsibility of the Sponsor Answer: TRUE QUESTION What are examples of human pharmacology studies? Answer: 1. drug tolerance studies 2. drug interaction studies 3. PKs and PDs studies QUESTION What phase are most human pharmacology studies? Answer: Phase I QUESTION What is Phase III also known as? Answer: Therapeutic confirmatory QUESTION What is Phase II also known as? Answer: Therapeutic exploratory QUESTION What is Phase I also known as? Answer: Human pharmacology QUESTION What is an excipient? Answer: An inactive substance that serves as a vehicle or medium for a drug or other active substance QUESTION What are the 3 principles of the Belmont Report? Answer: 1. Respect for persons 2. Beneficence 3. Justice QUESTION How long does the FDA have to review an IND? Answer: 30 days QUESTION True or False: Conmeds do not need to be included in the SAE report. Answer: FALSE QUESTION What is the difference between pharmacokinetics and pharmacodynamics? Answer: PK: movement of drug within the body PD: how the drug affects the organism QUESTION The IRB can waive the requirement for assent (in children) if it determines: Answer: 1. children are incapable of understanding the research 2. There's a prospect of direct benefit to the children that is not available outside of the research QUESTION What are 3 types of comparison trials? Answer: 1. trials to show superiority 2. trials to show equivalence/non-inferiority 3. trials to show dose-response relationship QUESTION How many days does a sponsor have to report an emergency use of an IP to the FDA? Answer: 5 working days 4. 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 QUESTION True or False: Pharmacokinetic (PK) studies are only conducted in Phase I trials Answer: FALSE: usually conducted in Phase I but can be measured in other phases too QUESTION True or False: Pharmacodynamics (PD) can be studied in people with AND without the disease of interest Answer: TRUE QUESTION What are the purposes & characteristics of Phase II studies? Answer: 1. Explore therapeutic efficacy 2. 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) QUESTION True or False: Doses used in Phase II trials are USUALLY less than the highest dose used in Phase I trials. Answer: TRUE QUESTION What are the purposes/characteristics of Phase III trials? Answer: 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 conditions 3. Wider more heterogenous participant population QUESTION What are the purposes/characteristics of Phase IV trials? Answer: 1. After drug approval by regulatory authorities 2. Studies not necessary for approval, but important for optimizing the drug's use 3. Examples of study types: -epidemiological -mortality/morbidity -drug interactions QUESTION Dose Escalation Designs vs Parallel Dose-Response Designs Answer: 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 QUESTION What happens if there are drug reactions to the placebo or active comparator drug? Answer: -Sponsor's decision on whether to report to regulatory authorities and/or manufacturer -Usually do not satisfy the criteria for expedited reporting QUESTION 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? Answer: Err on the side of over-reporting than under-reporting. Do the expedited report since the ADR is not expected in THIS particular situation QUESTION 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). QUESTION 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 analysis d) suspension of trial Answer: c) root cause analysis QUESTION If attempts to secure compliance at a site have failed, should sponsor... a) terminate the site b) re-train the site & develop a corrective plan Answer: a) terminate the site QUESTION What is "Phase IV" also known as? Answer: Therapeutic Use QUESTION What are ways to minimize the amount of blood drawn and/or number of venipunctures from pediatric patients? Answer: -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 QUESTION Pharmacokinetic Phase I studies in children are generally conducted in healthy pediatric subjects. True or False? Answer: FALSE QUESTION What is the name of the assessment used to stage a youth's pubertal development? Answer: Tanner Staging