ACRP CCRC Exam | Questions with 100% Correct
Answers | Verified | Latest Update 2026/2027
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Terms in this set (138)
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 representative person whom is lawfully able to 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 IRB? *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.... prorated & not contingent on subject completing
study
Answers | Verified | Latest Update 2026/2027
Save
Terms in this set (138)
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 representative person whom is lawfully able to 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 IRB? *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.... prorated & not contingent on subject completing
study
