CCRC COMPREHENSIVE EXAM 2026 FULL
QUESTIONS AND SOLUTIONS 100% CORRECT
◉ 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
QUESTIONS AND SOLUTIONS 100% CORRECT
◉ 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
