Exam (elaborations)
ACRP CCRC EXAM Updated Questions and Answers (2024/2025) (Verified Answers)
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ACRP CCRC EXAM Updated Questions and Answers (2024/2025) (Verified Answers)
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ACRP CCRC EXAM.pdf file:///C:/Users/HP/Desktop/New%20folder%20(4)/ACRP%20CCRACRP CCRC
1. ADR: Adverse Drug Reaction
2. Audit: Reviews how the research was conducted; takes into account SOPs, IRB
requirements & GCP (ensures compliance)
3. Audit Certificate: Confirmation audit took place
4. Audit Report: Written Evaluation - not regularly made available to regulatory
body; only when serious evidence exists concerning non-compliance
5. Audit Trail: Documentation of audit events
6. Single Blind Study: Subjects Unaware
7. Double Blind Study: Subjects & Researchers are unaware
8. Comparator: Item used as an active control references in a clinical trail
9. Coordinating Committee: Group a sponsor comprises to coordinate multi-cen-
ter trials
10. Coordinating Investigator: An investigator who oversees multiple sites of a
clinical trial (multicenter)
11. IDMC: Independent Data Monitoring Committee, Data & Safety Monitoring
Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make
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recommendations to continue, modify or stop
12. IEC: Independent Ethics Committee; group who oversees protection, rights,
safety & well-being of human subjects
13. Investigator's Brochure: Compilation of data on an investigational product
used in human subjects
14. Legally acceptable representative: person whom is lawfully able to consent
on behalf of another
15. 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
16. Source data: original clinical information from source documents (medical
record information)
17. Vulnerable subjects: *Hierarchical structure employees
*armed forces
*detainees
*incurable disease pts
*homeless
*poor
*those in nursing home
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*minors
*those unable to give consent
18. ICH: International Conference on Harmonization
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19. Principles of ICH & GCP: *Protect research subjects
*conduct research as it has been approved
*research should be clear, organized & approved by an IRB/IEC
20. IRB / IEC Responsibilities: *Oversee principles of ICH/GCP
*Make sure the PI / Co-Is are qualified
* Review studies at least once a year
21. Requirements of an IRB: * at least 5 members
* one non-scientific member
* one non-institute member
22. What needs reported to the IRB?: *Changes / deviations from protocol due to
unforeseen hazard
* changes to subject risk
* adverse events
* new info that may impact subject safety
23. Payment to subjects must be....: prorated & not contingent on subject com-
pleting study
24. Investigator Responsibilities: *Maintain delegation long
*Ensure staff are trained/informed about the protocol (give delegated tasks)
* Ascertain reason study participant withdraws consent while respecting their priva-
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