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CCRC Exam Prep - GCP E6(R2) Glossary Study Guide

CCRC Exam Prep - GCP E6(R2) Glossary Study Guide

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)

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