ACRP CCRC Exam Questions with Correct Answers.

ACRP CCRC Exam
Questions with
Correct Answers
petel petish [Date] [Course title]

,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



Source data - Correct Answer: original clinical information from source
documents (medical record information)



Vulnerable subjects - Correct Answer: *Hierarchical structure employees

*armed forces

*detainees

*incurable disease pts

*homeless

*poor

*those in nursing home

*minors

*those unable to give consent



ICH - Correct Answer: International Conference on Harmonization

, Principles of ICH & GCP - Correct Answer: *Protect research subjects

*conduct research as it has been approved

*research should be clear, organized & approved by an IRB/IEC



IRB / IEC Responsibilities - Correct Answer: *Oversee principles of ICH/GCP

*Make sure the PI / Co-Is are qualified

* Review studies at least once a year



Requirements of an IRB - Correct Answer: * at least 5 members

* one non-scientific member

* one non-institute member



What needs reported to the IRB? - Correct Answer: *Changes / deviations
from protocol due to unforeseen hazard

* changes to subject risk

* adverse events

* new info that may impact subject safety



Payment to subjects must be.... - Correct Answer: prorated & not contingent
on subject completing study



Investigator Responsibilities - Correct Answer: *Maintain delegation long

*Ensure staff are trained/informed about the protocol (give delegated tasks)

* Ascertain reason study participant withdraws consent while respecting their
privacy & rights

* Adhere to approved protocol

*Document & explain any deviations from approved protocol

* Process protocol amendments according to GCP