ACRP CCRC 2024 (All Correctly Answered)

ADR correct answers Adverse Drug Reaction Audit correct answers Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate correct answers Confirmation audit took place Audit Report correct answers Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail correct answers Documentation of audit events Single Blind Study correct answers Subjects Unaware Double Blind Study correct answers Subjects & Researchers are unaware Comparator correct answers Item used as an active control references in a clinical trail Coordinating Committee correct answers Group a sponsor comprises to coordinate multi-center trials Coordinating Investigator correct answers An investigator who oversees multiple sites of a clinical trial (multicenter) IDMC correct answers Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or stop IEC correct answers Independent Ethics Committee; group who oversees protection, rights, safety & well-being of human subjects Investigator's Brochure correct answers Compilation of data on an investigational product used in human subjects Legally acceptable representative correct answers person whom is lawfully able to consent on behalf of another SAE correct answers 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 correct answers original clinical information from source documents (medical record information)