ACRP CCRC Exam Test with Answers
1. ADR Adverse Drug Re-
action
2. Audit Reviews how the
research was con-
ducted; takes into
account SOPs,
IRB requirements
& GCP (ensures
compl
ACRP CCRC Exam Test with Answers
1. ADR Adverse Drug Re-
action
2. Audit Reviews how the
research was con-
ducted; takes into
account SOPs,
IRB requirements
& GCP (ensures
compliance)
3. Audit Certificate Confirmation audit
took place
4. Audit Report Written Evaluation
- not regular-
ly made avail-
able to regulato-
ry body; only when
serious evidence
exists concerning
non-compliance
5. Audit Trail Documentation of
audit events
6. Single Blind Study Subjects Unaware
7. Double Blind Study Subjects & Re-
searchers are un-
aware
8. Comparator Item used as an
active control refer-
ences in a clinical
trail
9. Coordinating Committee Group a sponsor
comprises to coor-
, ACRP CCRC Exam Test with Answers
dinate multi-center
trials
10. Coordinating Investigator An investigator
who oversees mul-
tiple sites of a clin-
ical trial (multicen-
ter)
11. IDMC Independent Data
Monitoring Com-
mittee, Data &
Safety Monitoring
Board (DSMB),
Data Monitor-
ing Committee:
Oversee safe-
ty & progress;
make recommen-
dations to contin-
ue, modify or stop
12. IEC Independent
Ethics Committee;
group who
oversees
protection, rights,
safety & well-being
of human subjects
13. Investigator's Brochure Compilation of data
on an investigation-
al product used in
human subjects
14. Legally acceptable representative person whom is
lawfully able to
consent on behalf
of another
, ACRP CCRC Exam Test with Answers
15. SAE Serious Adverse
Event - Re-
sults in death,
is life-threatening,
requires long-term
hospitalization, re-
sults in long
term disability/hos-
pitalization inca-
pacitation or is a
congenital birth de-
fect
16. Source data original clinical
information from
source documents
(medical record in-
formation)
17. Vulnerable subjects *Hierarchical struc-
ture employees
*armed forces
*detainees
*incurable disease
pts
*homeless
*poor
*those in nursing
home
*minors
*those unable to
give consent
18. ICH International Con-
ference on Harmo-
nization
19. Principles of ICH & GCP *Protect research
subjects
*conduct research
, ACRP CCRC Exam Test with Answers
as it has been ap-
proved
*research should
be clear, organized
& approved by an
IRB/IEC
20. IRB / IEC Responsibilities *Oversee princi-
ples of ICH/GCP
*Make sure the PI /
Co-Is are qualified
* Review studies at
least once a year
21. Requirements of an IRB * at least 5 mem-
bers
* one non-scientific
member
* one non-institute
member
22. What needs reported to the IRB? *Changes / devia-
tions from protocol
due to unforeseen
hazard
* changes to sub-
ject risk
* adverse events
* new info that
may impact subject
safety
23. Payment to subjects must be.... prorated & not con-
tingent on subject
completing study
24. Investigator Responsibilities *Maintain delega-
tion long
*Ensure staff
are trained/in-
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