ACRP CCRC exam 2023 with complete solutions

ADR - Answer Adverse Drug Reaction Audit - Answer Reviews how the research was conducted; takes into account SOPs, IRB requirements and GCP (ensures compliance) Audit Certificate - Answer Confirmation audit took place Audit Report - Answer Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Answer Documentation of audit events Single Blind Study - Answer Subjects Unaware Double Blind Study - Answer Subjects & Researchers are unaware Comparator - Answer Item used as an active control references in a clinical trail Coordinating Committee - Answer Group a sponsor comprises to coordinate multicenter trials Coordinating Investigator - Answer An investigator who oversees multiple sites of a clinical trial (multicenter) IDMC - Answer Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or stop IEC - Answer Independent Ethics Committee; group who oversees protection, rights, safety and well-being of human subjects Investigator's Brochure - Answer Compilation of data on an investigational product used in human subjects Legally acceptable representative - Answer person whom is lawfully able to consent on behalf of another SAE - Answer Serious Adverse Event - Results in death, is life-threatening, requires long-term hospitalization, results in long term disability/hospitalization incapacitation or is a congenital birth defect Source data - Answer original clinical information from source documents (medical record information) Vulnerable subjects - Answer *Hierarchical structure employees *armed forces *detainees *incurable disease pts *homeless *poor *those in nursing home *minors *those unable to give consent