ACRP exam questions & answers graded A+ 2023/2024

ACRP examALCOAC - correct answer Accurate, legible, contemporaneous, original, attributable, complete Good Clinical Practice (GCP) - correct answer A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. ICH - correct answer international conference of harmonization- provides a unified standard for the European union, Japan & US to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. ICH E6 - correct answer Guideline for Good Clinical Practice ICH E8 - correct answer Guidance on General Considerations for Clinical Trials - provides study design information, the objective of the phases in terms of data focus, definitions & considerations ICH E2A - correct answer clinical safety data reporting - provides safety definitions & reporting timeframe requirements Phase 1 - correct answer 20-80 patients, time:several weeks to a month, purpose:mainly safety, design: dose escalation, typically open-label, single center, subjects: healthy volunteers (except when drug is toxic to healthy people) Phase 2 - correct answer several hundred patients, time: several months to 2 yrs, purpose: safety & effectiveness, dose ranging, therapeutic exploratory, design: blinded, randomized, strict inclusion/exclusion subjects: people with the indication under study Phase 3 - correct answer size: hundreds to thousands, time: years, purpose: safety & effectiveness, less common side effects, therapeutic confirmatory, design: blinded, randomized, controlled, general population, subjects: ppl with the study disease