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
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
