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 1. Either a new med product OR existing med product with new usages 2. Must be causal relationship In post-marketed products 1. 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: 1. Any UNEXPECTED SERIOUS ADR 2. Increased rate of occurrence of EXPECTED SERIOUS ADR 3. 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 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: 1. patient info (study #, DOB, sex, etc.) 2. suspected med. products (brand, batch #, dosage form, indication, route of admin, etc.) 3. other treatment/therapies 4. details of event (outcome, setting, start/stop dates, etc.) 5. contact info of reporter 6. 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