CCRC Exam Prep - GCP E6(R2) Glossary
Study Guide
Pre-Approved clincal experience - all noxious and unintended responses to a medical
product related to any dose
Marketed Medicinal products- a response to a drug which is noxious and unintended
and which occurs at doess normally used. (ICH GCP E6 1.1) - Adverse Drug Reaction
(ADR)
Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a causal
relationship with this treatment. (ICH GCP E6 1.2) - Adverse Event (AE)
Any laws and regulations addressing the conduct of clinical trials of investigational
products (ICH GCP E6 1.4) - Applicable regulatory Requirement(s)
The affirmative decision of the IRB that the clinical trial has been reviewed and may be
conducted at the institution site within the constraints set forth by the IRB, the institution,
CGP and the applicable regulatory requirements (ICH GCP E6 1.5) - Approval ( in
relation to IRBs)
A systematic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data
were recorded, analyszed and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirments(s) (ICH GCP E6 1.6 - Audit
A declaration of confirmation by the auditor that an audit has taken place. (ICH GCP E6
1.7) - Audit Certificate
A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6
1.8) - Audit Report
Documentation that allows reconstruction of the course of events. (ICH GCP E6 1.9) -
Audit Trail
A procedure in which one or more parties to the trial are kept unaware of the treatment
assignment. (ICH GCP E6 1.10) - Blinding/Masking
A printed, optical, or electronic docuement designed to record all of the protocol
required informaiton to be reported to the sponsor on each trial subject. (ICH GCP E6
1.11) - Case Report Form (CRF)
, Any investigation in human subjects intended to discover or verify the clinical,
pharmacological, and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism, and excretion of an investigational
product(s) with the object of ascertaining its safety and/or efficacy. (ICH GCP6 E6 1.12)
- Clinical Trial/Study
A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent
conducted in human subjects, in which the clinical and statistical description,
presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13) -
Clinical Trial/ Study report
An investigational or marketed product (i.e., active control), or placebo, used as a
reference in a clinical trial.(ICH GCP E6 1.14) - Comparator (Product)
Adherence to all the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements. (ICH GCP E6 1.15) -
Compliance (in relation to trials)
Revention of disclosure, to other than authorized individuals, of a sponsor's proprietary
information or aof a subject's identity. (ICH GCP E6 1.16) - Confidentiality
A written, dated, and signed agreement between two or more involved parties that sets
out any arrangements on delegation and distribution of tasks and obligations and, if
appropriate, on financial matters. The protocol may serve as the basis of a contract.
(ICH GCP E6 1.17) - Contract
A committee that a sponsor may organize to coordinate the conduct of a multicentre
trial. (ICH GCP E6 1.18) - Coorinating Committe
An investigator assigned the responsibility for the coordination of investigators at
different centers participating in a multicenter trial.(ICH GCP E6 1.19) - Coordinating
Investigator
A person or an organization (commercial, academic, or other) contracted by the sponsor
to perform one or more of a sponsor's trial-related duties and functions (ICH GCP E6
1.20) - Contract Research Orgnization (CRO)
Permission to examine, analyze, verify, and reproduce any records and reports that are
important to evaluation of a clinical trial. (ICH GCP E6 1.21) - Direct Access
All records, in any form that describe or record the methods, conduct, and/or results of a
trial, the factors affecting a trial, and the actions taken. (ICH GCP E6 1.22) -
Documentation
