ACRP CCRC EXAM | QUESTIONS AND ANSWERS |
NEW 2026 UPDATE | WITH COMPLETE SOLUTION
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
SAE 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 Answer - original clinical information from source documents
(medical record information)
Vulnerable subjects Answer - *Hierarchical structure employees
*armed forces
*detainees
*incurable disease pts
*homeless
*poor
,*those in nursing home
*minors
*those unable to give consent
ICH Answer - International Conference on Harmonization
Principles of ICH & GCP Answer - *Protect research subjects
*conduct research as it has been approved
*research should be clear, organized & approved by an IRB/IEC
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
*Experimental Aspects of trial
*Risks
NEW 2026 UPDATE | WITH COMPLETE SOLUTION
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
SAE 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 Answer - original clinical information from source documents
(medical record information)
Vulnerable subjects Answer - *Hierarchical structure employees
*armed forces
*detainees
*incurable disease pts
*homeless
*poor
,*those in nursing home
*minors
*those unable to give consent
ICH Answer - International Conference on Harmonization
Principles of ICH & GCP Answer - *Protect research subjects
*conduct research as it has been approved
*research should be clear, organized & approved by an IRB/IEC
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
*Experimental Aspects of trial
*Risks
