ACRP CCRC EXAM WITH CORRECT
ANSWERS 2025
ADR ( correct answers ) Adverse Drug Reaction
Audit ( correct answers ) Reviews how the research was conducted;
takes into account SOPs, IRB requirements & GCP (ensures compliance)
Audit Certificate ( correct answers ) Confirmation audit took
place
Audit Report ( correct answers ) Written Evaluation - not regularly made
available to regulatory body; only when serious evidence exists concerning
non-compliance
Audit Trail ( correct answers ) Documentation of audit
events Single Blind Study ( correct answers )
Subjects Unaware
Double Blind Study ( correct answers ) Subjects &
Researchers are unaware
Comparator ( correct answers ) Item used as an active control references
in a clinical trail
Coordinating Committee ( correct answers ) Group a sponsor
comprises to coordinate multi-center trials
Coordinating Investigator ( correct answers ) An investigator who
oversees multiple sites of a clinical trial (multicenter)
IDMC ( correct answers ) Independent Data Monitoring Committee,
Data & Safety Monitoring Board (DSMB), Data Monitoring Committee:
Oversee safety & progress; make recommendations to continue, modify or
stop
IEC ( correct answers ) Independent Ethics Committee; group who
oversees protection, rights, safety & well-being of human subjects
Investigator's Brochure ( correct answers ) Compilation of data on an
investigational product used in human subjects
Legally acceptable representative ( correct answers ) person whom is
lawfully able to consent on behalf of another
,SAE ( correct answers ) 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 answers ) original clinical information from
source documents (medical record information)
Vulnerable subjects ( correct answers ) *Hierarchical
structure employees
*armed forces
*detainees
*incurable disease pts
*homeless
*poor
*those in nursing home
*minors
*those unable to give consent
ICH ( correct answers ) International Conference on
Harmonization Principles of ICH & GCP ( correct answers )
*Protect research subjects
*conduct research as it has been approved
*research should be clear, organized & approved by an IRB/IEC
IRB / IEC Responsibilities ( correct answers ) *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 answers ) * at least 5
members
* one non-scientific member
* one non-institute member
What needs reported to the IRB? ( correct answers ) *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 answers )
prorated & not contingent on subject completing study
Investigator Responsibilities ( correct answers ) *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 ( correct answers ) 1.
IRB
2. Sponsor
3. Regulatory Authority
Changes in risk to subjects... ( correct answers ) should be included &
approved on an updated ICF - patients enrolled should be re-consented
Consenting illiterate subjects ( correct answers ) is
okay, but must have impartial witness present
Necessary aspects of ICF ( correct answers ) *Trial
involves research
*Trial purposes
*Treatments - randomization aspect if applicable
* Procedures
*Subject responsibilities
*Experimental Aspects of trial
*Risks
*Benefits
*Alternatives to participating
*Compensation
* Compensation for trial related outcomes
*Voluntary nature of trial
*Who has access to direct records
*Confidentiality of research records
*New information will be made available to subject
*Who to Contact
*Involuntary termination
*Trial Duration
Non-therapeutic trials can be conducted with consent from
*Subjects to be enrolled ( corre
legal rep IF answers ) *trial objectives cannot be met by ct
personal subject consent
*low risk
*trial is not prohibited by law
*IRB has approved such inclusion
How long must documents be retained per GCP? ( correct answers ) At
least 2 years after last approved marketing application
(organizations/sponsors, etc usually set a longer required period of 5-7 years)
When to submit SAE to sponsor? ( correct answers ) Immediately
(usually within 24 hours)
ANSWERS 2025
ADR ( correct answers ) Adverse Drug Reaction
Audit ( correct answers ) Reviews how the research was conducted;
takes into account SOPs, IRB requirements & GCP (ensures compliance)
Audit Certificate ( correct answers ) Confirmation audit took
place
Audit Report ( correct answers ) Written Evaluation - not regularly made
available to regulatory body; only when serious evidence exists concerning
non-compliance
Audit Trail ( correct answers ) Documentation of audit
events Single Blind Study ( correct answers )
Subjects Unaware
Double Blind Study ( correct answers ) Subjects &
Researchers are unaware
Comparator ( correct answers ) Item used as an active control references
in a clinical trail
Coordinating Committee ( correct answers ) Group a sponsor
comprises to coordinate multi-center trials
Coordinating Investigator ( correct answers ) An investigator who
oversees multiple sites of a clinical trial (multicenter)
IDMC ( correct answers ) Independent Data Monitoring Committee,
Data & Safety Monitoring Board (DSMB), Data Monitoring Committee:
Oversee safety & progress; make recommendations to continue, modify or
stop
IEC ( correct answers ) Independent Ethics Committee; group who
oversees protection, rights, safety & well-being of human subjects
Investigator's Brochure ( correct answers ) Compilation of data on an
investigational product used in human subjects
Legally acceptable representative ( correct answers ) person whom is
lawfully able to consent on behalf of another
,SAE ( correct answers ) 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 answers ) original clinical information from
source documents (medical record information)
Vulnerable subjects ( correct answers ) *Hierarchical
structure employees
*armed forces
*detainees
*incurable disease pts
*homeless
*poor
*those in nursing home
*minors
*those unable to give consent
ICH ( correct answers ) International Conference on
Harmonization Principles of ICH & GCP ( correct answers )
*Protect research subjects
*conduct research as it has been approved
*research should be clear, organized & approved by an IRB/IEC
IRB / IEC Responsibilities ( correct answers ) *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 answers ) * at least 5
members
* one non-scientific member
* one non-institute member
What needs reported to the IRB? ( correct answers ) *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 answers )
prorated & not contingent on subject completing study
Investigator Responsibilities ( correct answers ) *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 ( correct answers ) 1.
IRB
2. Sponsor
3. Regulatory Authority
Changes in risk to subjects... ( correct answers ) should be included &
approved on an updated ICF - patients enrolled should be re-consented
Consenting illiterate subjects ( correct answers ) is
okay, but must have impartial witness present
Necessary aspects of ICF ( correct answers ) *Trial
involves research
*Trial purposes
*Treatments - randomization aspect if applicable
* Procedures
*Subject responsibilities
*Experimental Aspects of trial
*Risks
*Benefits
*Alternatives to participating
*Compensation
* Compensation for trial related outcomes
*Voluntary nature of trial
*Who has access to direct records
*Confidentiality of research records
*New information will be made available to subject
*Who to Contact
*Involuntary termination
*Trial Duration
Non-therapeutic trials can be conducted with consent from
*Subjects to be enrolled ( corre
legal rep IF answers ) *trial objectives cannot be met by ct
personal subject consent
*low risk
*trial is not prohibited by law
*IRB has approved such inclusion
How long must documents be retained per GCP? ( correct answers ) At
least 2 years after last approved marketing application
(organizations/sponsors, etc usually set a longer required period of 5-7 years)
When to submit SAE to sponsor? ( correct answers ) Immediately
(usually within 24 hours)
