ACRP CCRC Exam Questions and Answers
with Verified Solutions | Latest Updated
2026
ADR Adverse Drug Reaction
Audit Reviews how the research was
conducted; takes into account SOPs,
IRB requirements & GCP (ensures
compliance)
Audit Certificate Confirmation audit took place
Audit Report Written Evaluation-not regularly
made available to regulatory body;
only when serious evidence exists
concerning non-compliance
Audit Trail Documentation of audit events
Single Blind Study Subjects Unaware
Double Blind Study Subjects & Researchers are unaware
Comparator Item used as an active control
references in a clinical trail
Coordinating Committee Group a sponsor comprises to
coordinate multi-center trials
,Coordinating Investigator An investigator who oversees
multiple sites of a clinical trial
(multicenter)
IDMC Independent Data Monitoring
Committee, Data & Safety
Monitoring Board (DSMB), Data
Monitoring Committee: Oversee
safety & progress; make
recommendations to continue,
modify or stop
IEC Independent Ethics Committee;
group who oversees protection,
rights, safety & well-being of human
subjects
Investigator's Brochure Compilation of data on an
investigational product used in
human subjects
Legally acceptable person whom is lawfully able to
representative consent on behalf of another
SAE 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 original clinical information from
source documents (medical record
, information)
Vulnerable subjects *Hierarchical structure employees
*armed forces *detainees *incurable
disease pts *homeless *poor *those
in nursing home *minors *those
unable to give consent
ICH International Conference on
Harmonization
Principles of ICH & GCP *Protect research subjects *conduct
research as it has been approved
*research should be clear, organized
& approved by an IRB/IEC
IRB / IEC Responsibilities *Oversee principles of ICH/GCP
*Make sure the PI / Co-Is are
qualified * Review studies at least
once a year
Requirements of an IRB * at least 5 members * one
non-scientific member * one
non-institute member
What needs reported to the *Changes / deviations from protocol
IRB? due to unforeseen hazard * changes
to subject risk * adverse events *
new info that may impact subject
safety
Payment to subjects must prorated & not contingent on subject
be.... completing study
with Verified Solutions | Latest Updated
2026
ADR Adverse Drug Reaction
Audit Reviews how the research was
conducted; takes into account SOPs,
IRB requirements & GCP (ensures
compliance)
Audit Certificate Confirmation audit took place
Audit Report Written Evaluation-not regularly
made available to regulatory body;
only when serious evidence exists
concerning non-compliance
Audit Trail Documentation of audit events
Single Blind Study Subjects Unaware
Double Blind Study Subjects & Researchers are unaware
Comparator Item used as an active control
references in a clinical trail
Coordinating Committee Group a sponsor comprises to
coordinate multi-center trials
,Coordinating Investigator An investigator who oversees
multiple sites of a clinical trial
(multicenter)
IDMC Independent Data Monitoring
Committee, Data & Safety
Monitoring Board (DSMB), Data
Monitoring Committee: Oversee
safety & progress; make
recommendations to continue,
modify or stop
IEC Independent Ethics Committee;
group who oversees protection,
rights, safety & well-being of human
subjects
Investigator's Brochure Compilation of data on an
investigational product used in
human subjects
Legally acceptable person whom is lawfully able to
representative consent on behalf of another
SAE 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 original clinical information from
source documents (medical record
, information)
Vulnerable subjects *Hierarchical structure employees
*armed forces *detainees *incurable
disease pts *homeless *poor *those
in nursing home *minors *those
unable to give consent
ICH International Conference on
Harmonization
Principles of ICH & GCP *Protect research subjects *conduct
research as it has been approved
*research should be clear, organized
& approved by an IRB/IEC
IRB / IEC Responsibilities *Oversee principles of ICH/GCP
*Make sure the PI / Co-Is are
qualified * Review studies at least
once a year
Requirements of an IRB * at least 5 members * one
non-scientific member * one
non-institute member
What needs reported to the *Changes / deviations from protocol
IRB? due to unforeseen hazard * changes
to subject risk * adverse events *
new info that may impact subject
safety
Payment to subjects must prorated & not contingent on subject
be.... completing study
