ACRP CCRC QUESTIONS AND ANSWERS
100% CORRECT
ADR Correct Answer: Adverse Drug Reaction
Audit Correct Answer: Reviews how the research was conducted; takes into account SOPs, IRB
requirements & GCP (ensures compliance)
Audit Certificate Correct Answer: Confirmation audit took place
Audit Report Correct Answer: Written Evaluation - not regularly made available to regulatory
body; only when serious evidence exists concerning non-compliance
Audit Trail Correct Answer: Documentation of audit events
Single Blind Study Correct Answer: Subjects Unaware
Double Blind Study Correct Answer: Subjects & Researchers are unaware
Comparator Correct Answer: Item used as an active control references in a clinical trail
Coordinating Committee Correct Answer: Group a sponsor comprises to coordinate multi-center
trials
Coordinating Investigator Correct Answer: An investigator who oversees multiple sites of a
clinical trial (multicenter)
IDMC Correct Answer: Independent Data Monitoring Committee, Data & Safety Monitoring
Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make
recommendations to continue, modify or stop
IEC Correct Answer: Independent Ethics Committee; group who oversees protection, rights,
safety & well-being of human subjects
Investigator's Brochure Correct Answer: Compilation of data on an investigational product used
in human subjects
Legally acceptable representative Correct Answer: person whom is lawfully able to consent on
behalf of another
SAE Correct 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