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ACRP CCRC questions n answers graded A+
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ACRP CCRC questions n answers graded A+
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ACRP CCRCADR - 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 answer ✔✔An 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 -
PharmD, etc)
Protocol amendments should be submitted to - correct answer ✔✔1. IRB
2. Sponsor
3. Regulatory Authority
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