ACRP CCRC| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE!! Pass
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Course
ACRP CCRC
Institution
ACRP CCRC
ADR
Adverse Drug Reaction
Audit
Reviews how the research was conducted; takes into account SOPs, IRB requirements &
GCP (ensures compliance)
Audit Certificate
Confirmation audit took place
Audit Report
Written Evaluation - not regularly made available to regulatory body; only when seri...
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✓ Subjects Unaware
Double Blind Study
✓ Subjects & Researchers are unaware
Comparator
✓ Item used as an active control references in a clinical trail
Coordinating Committee
✓ Group a sponsor comprises to coordinate multi-center trials
Coordinating Investigator
✓ An investigator who oversees multiple sites of a clinical trial (multicenter)
IDMC
✓ Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB),
Data Monitoring Committee: Oversee safety & progress; make recommendations to
continue, modify or stop
IEC
✓ Independent Ethics Committee; group who oversees protection, rights, safety & well-being
of human subjects
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✓ Compilation of data on an investigational product used in human subjects
Legally acceptable representative
✓ person whom is lawfully able to consent on behalf of another
SAE
✓ 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
✓ original clinical information from source documents (medical record information)
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