CRA ACRP COMPREHENSIVE EXAM SCRIPT COMPLETE QUESTIONS VERIFIED SOLUTIONS
Question:
Audit
Answer:
Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP
(ensures compliance)
Question:
Audit Certificate
Answer:
Confirmation audit took place
Question:
Audit Report
Answer:
Written Evaluation - not regularly made available to regulatory body; only when serious evidence
exists concerning non-compliance
Question:
Audit Trail
Answer:
Documentation of audit events
Question:
,Single Blind Study
Answer:
Subjects Unaware
Question:
Double Blind Study
Answer:
Subjects & Researchers are unaware
Question:
Comparator
Answer:
Item used as an active control references in a clinical trail
Question:
Coordinating Committee
Answer:
Group a sponsor comprises to coordinate multi-center trials
Question:
Coordinating Investigator
Answer:
An investigator who oversees multiple sites of a clinical trial (multicenter)
Question:
IDMC
,Answer:
Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data
Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or
stop
Question:
IEC
Answer:
Independent Ethics Committee; group who oversees protection, rights, safety & well-being of
human subjects
Question:
Investigator's Brochure
Answer:
Compilation of data on an investigational product used in human subjects
Question:
Legally acceptable representative
Answer:
person whom is lawfully able to consent on behalf of another
Question:
SAE
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
Question:
, Source data
Answer:
original clinical information from source documents (medical record information)
Question:
Vulnerable subjects
Answer:
*Hierarchical structure employees *armed forces *detainees *incurable disease pts *homeless *poor
*those in nursing home *minors *those unable to give consent
Question:
ICH
Answer:
International Conference on Harmonization
Question:
Principles of ICH & GCP
Answer:
*Protect research subjects *conduct research as it has been approved *research should be clear,
organized & approved by an IRB/IEC
Question:
IRB / IEC Responsibilities
Answer:
*Oversee principles of ICH/GCP *Make sure the PI / Co-Is are qualified * Review studies at least
once a year
Question:
Audit
Answer:
Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP
(ensures compliance)
Question:
Audit Certificate
Answer:
Confirmation audit took place
Question:
Audit Report
Answer:
Written Evaluation - not regularly made available to regulatory body; only when serious evidence
exists concerning non-compliance
Question:
Audit Trail
Answer:
Documentation of audit events
Question:
,Single Blind Study
Answer:
Subjects Unaware
Question:
Double Blind Study
Answer:
Subjects & Researchers are unaware
Question:
Comparator
Answer:
Item used as an active control references in a clinical trail
Question:
Coordinating Committee
Answer:
Group a sponsor comprises to coordinate multi-center trials
Question:
Coordinating Investigator
Answer:
An investigator who oversees multiple sites of a clinical trial (multicenter)
Question:
IDMC
,Answer:
Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data
Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or
stop
Question:
IEC
Answer:
Independent Ethics Committee; group who oversees protection, rights, safety & well-being of
human subjects
Question:
Investigator's Brochure
Answer:
Compilation of data on an investigational product used in human subjects
Question:
Legally acceptable representative
Answer:
person whom is lawfully able to consent on behalf of another
Question:
SAE
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
Question:
, Source data
Answer:
original clinical information from source documents (medical record information)
Question:
Vulnerable subjects
Answer:
*Hierarchical structure employees *armed forces *detainees *incurable disease pts *homeless *poor
*those in nursing home *minors *those unable to give consent
Question:
ICH
Answer:
International Conference on Harmonization
Question:
Principles of ICH & GCP
Answer:
*Protect research subjects *conduct research as it has been approved *research should be clear,
organized & approved by an IRB/IEC
Question:
IRB / IEC Responsibilities
Answer:
*Oversee principles of ICH/GCP *Make sure the PI / Co-Is are qualified * Review studies at least
once a year
