ACRP CCRC EXAM QUESTIONS AND
ANSWERS 100% CORRECT!!
,ADR - ANSWER Adverse Drug Reaction
Audit - ANSWER Reviews how the research was conducted; takes into account SOPs,
IRB requirements & GCP (ensures compliance)
Audit Certificate - ANSWER Confirmation audit took place
Audit Report - ANSWER Written Evaluation - not regularly made available to regulatory
body; only when serious evidence exists concerning non-compliance
Audit Trail - ANSWER Documentation of audit events
Single Blind Study - ANSWER Subjects Unaware
Double Blind Study - ANSWER Subjects & Researchers are unaware
Comparator - ANSWER Item used as an active control references in a clinical trail
Coordinating Committee - ANSWER Group a sponsor comprises to coordinate multi-
center trials
Coordinating Investigator - ANSWER An investigator who oversees multiple sites of a
clinical trial (multicenter)
IDMC - ANSWER Independent Data Monitoring Committee, Data & Safety Monitoring
Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make
recommendations to continue, modify or stop
IEC - ANSWER Independent Ethics Committee; group who oversees protection, rights,
safety & well-being of human subjects
Investigator's Brochure - ANSWER Compilation of data on an investigational product
used in human subjects
Legally acceptable representative - ANSWER person whom is lawfully able to consent
on behalf of another
IRB / IEC Responsibilities - 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 - ANSWER * at least 5 members
* one non-scientific member
* one non-institute member
What needs reported to the IRB? - 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.... - ANSWER prorated & not contingent on subject
completing study
Investigator Responsibilities - 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
*Manage proper storage & care for trial devices/drugs. (PI can delegate this task to
trained professional - PharmD, etc)
Protocol amendments should be submitted to - ANSWER 1. IRB
2. Sponsor
3. Regulatory Authority
Changes in risk to subjects... - ANSWER should be included & approved on an updated
ICF - patients enrolled should be re-consented
Consenting illiterate subjects - ANSWER is okay, but must have impartial witness
present
Necessary aspects of ICF - ANSWER *Trial involves research
*Trial purposes
*Treatments - randomization aspect if applicable
* Procedures
*Subject responsibilities
ANSWERS 100% CORRECT!!
,ADR - ANSWER Adverse Drug Reaction
Audit - ANSWER Reviews how the research was conducted; takes into account SOPs,
IRB requirements & GCP (ensures compliance)
Audit Certificate - ANSWER Confirmation audit took place
Audit Report - ANSWER Written Evaluation - not regularly made available to regulatory
body; only when serious evidence exists concerning non-compliance
Audit Trail - ANSWER Documentation of audit events
Single Blind Study - ANSWER Subjects Unaware
Double Blind Study - ANSWER Subjects & Researchers are unaware
Comparator - ANSWER Item used as an active control references in a clinical trail
Coordinating Committee - ANSWER Group a sponsor comprises to coordinate multi-
center trials
Coordinating Investigator - ANSWER An investigator who oversees multiple sites of a
clinical trial (multicenter)
IDMC - ANSWER Independent Data Monitoring Committee, Data & Safety Monitoring
Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make
recommendations to continue, modify or stop
IEC - ANSWER Independent Ethics Committee; group who oversees protection, rights,
safety & well-being of human subjects
Investigator's Brochure - ANSWER Compilation of data on an investigational product
used in human subjects
Legally acceptable representative - ANSWER person whom is lawfully able to consent
on behalf of another
IRB / IEC Responsibilities - 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 - ANSWER * at least 5 members
* one non-scientific member
* one non-institute member
What needs reported to the IRB? - 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.... - ANSWER prorated & not contingent on subject
completing study
Investigator Responsibilities - 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
*Manage proper storage & care for trial devices/drugs. (PI can delegate this task to
trained professional - PharmD, etc)
Protocol amendments should be submitted to - ANSWER 1. IRB
2. Sponsor
3. Regulatory Authority
Changes in risk to subjects... - ANSWER should be included & approved on an updated
ICF - patients enrolled should be re-consented
Consenting illiterate subjects - ANSWER is okay, but must have impartial witness
present
Necessary aspects of ICF - ANSWER *Trial involves research
*Trial purposes
*Treatments - randomization aspect if applicable
* Procedures
*Subject responsibilities
