ADR 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 -...
ACRP CCRC QUESTIONS AND
ANSWERS 100% CORRECT
ADR 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
Changes in risk to subjects... Correct Answer: should be included & approved on an updated
ICF - patients enrolled should be re-consented
Consenting illiterate subjects Correct Answer: is okay, but must have impartial witness present
Necessary aspects of ICF Correct Answer: *Trial involves research
*Trial purposes
*Treatments - randomization aspect if applicable
* Procedures
*Subject responsibilities
*Experimental Aspects of trial
*Risks
*Benefits
*Alternatives to participating
*Compensation
* Compensation for trial related outcomes
*Voluntary nature of trial
*Who has access to direct records
*Confidentiality of research records
*New information will be made available to subject
*Who to Contact
*Involuntary termination
*Trial Duration
*Subjects to be enrolled
Non-therapeutic trials can be conducted with consent from legal rep IF Correct Answer: *trial
objectives cannot be met by personal subject consent
*low risk
*trial is not prohibited by law
*IRB has approved such inclusion
How long must documents be retained per GCP? Correct Answer: At least 2 years after last
approved marketing application (organizations/sponsors, etc usually set a longer required period
of 5-7 years)
When to submit SAE to sponsor? Correct Answer: Immediately (usually within 24 hours)
Sponsors role Correct Answer: *Complete & ensure SOPs are followed
*seeks agreements from all parties
*may use CRO to oversee; however, the sponsor is ultimately responsible
CRO Correct Answer: Contract Research Organization
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