ACRP CCRC EXAM latest version
2024/2025
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 Answering 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
*Manage proper storage & care for trial devices/drugs. (PI can delegate this task to
trained professional - Pharm, etc.)
Protocol amendments should be submitted to - CORRECT ANSWER1. IRB
2. Sponsor
3. Regulatory Authority
Changes in risk to subjects... - CORRECT ANSWER should be included & approved on
an updated ICF - patients enrolled should be re-consented
Consenting illiterate subjects - CORRECT Answers okay, but must have impartial
witness present
Necessary aspects of ICF - CORRECT ANSWER*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
*Subjects to be enrolled
Non-therapeutic trials can be conducted with consent from legal rep IF - CORRECT
ANSWER*trial objectives cannot be met by 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 ANSWER 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 ANSWER Immediately (usually within 24
hours)
2024/2025
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 Answering 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
*Manage proper storage & care for trial devices/drugs. (PI can delegate this task to
trained professional - Pharm, etc.)
Protocol amendments should be submitted to - CORRECT ANSWER1. IRB
2. Sponsor
3. Regulatory Authority
Changes in risk to subjects... - CORRECT ANSWER should be included & approved on
an updated ICF - patients enrolled should be re-consented
Consenting illiterate subjects - CORRECT Answers okay, but must have impartial
witness present
Necessary aspects of ICF - CORRECT ANSWER*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
*Subjects to be enrolled
Non-therapeutic trials can be conducted with consent from legal rep IF - CORRECT
ANSWER*trial objectives cannot be met by 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 ANSWER 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 ANSWER Immediately (usually within 24
hours)
