10/8/25, 8:31 AM ICH GCP for CCRC Exam Prep|2025 UPDATE| COMPLETE FREQUENTLY TESTED QUESTIONS WITH VERIFIED ANSWERS|G…
ICH GCP for CCRC Exam Prep|2025 UPDATE|
COMPLETE FREQUENTLY TESTED QUESTIONS
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Terms in this set (543)
Adverse Drug Reaction All noxious and unintended responses to a medicinal
(ADR) product related to any dose
E6(R1) 1 Glossary of terms
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
Adverse Event (AE)
treatment--any unfavorable and unintended sign ,
symptom, or disease temporally associated with the
use of a medicinal product, whether or not related to
the medicinal product
Applicable Regulatory Any law(s) and regulation(s) addressing the conduct
Requirements of clinical trials of investigational products
The affirmative decision of the IRB that the clinical trial
has been reviewed and may be conducted at the
Institutional Review Board
institution site within the constraints set forth by the
Approval
IRB, the institution, Good Clinical Practice (GCP), and
the applicable regulatory requirements
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, 10/8/25, 8:31 AM ICH GCP for CCRC Exam Prep|2025 UPDATE| COMPLETE FREQUENTLY TESTED QUESTIONS WITH VERIFIED ANSWERS|G…
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, analyzed
Audit
and accurately reported according to the protocol,
sponsor's standard operating procedures, (SOPs),
Good Clinical Practice (GCP), and the applicable
regulatory requirement(s)
A declaration of confirmation by the auditor that an
Audit Certificate
audit has taken place
A written evaluation by the sponsor's auditor of the
Audit Report
results of the audit
Documentation that allows reconstruction of the
Audit Trail
course of events
A procedure in which one or more parties to the trial
Blinding/Masking
are kept unaware of the treatment assignment(s).
A printed, optical, or electronic document designed
Case Report Form (CRF) to record all of the protocol required information to
be reported to the sponsor on each trial subject.
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
Clinical Trial/Study
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
A written description of a trial/study of any
therapeutic, prophylactic, or diagnostic agent
Clinical Trial/Study Report conducted in human subjects, in which the clinical and
statistical description, presentations, and analyses are
fully integrated into a single report
https://quizlet.com/1089420997/ich-gcp-for-ccrc-exam-prep2025-update-complete-frequently-tested-questions-with-verified-answersget-it-100-accura… 2/14
ICH GCP for CCRC Exam Prep|2025 UPDATE|
COMPLETE FREQUENTLY TESTED QUESTIONS
WITH VERIFIED ANSWERS|GET IT 100%
ACCURATE!!
Save
Terms in this set (543)
Adverse Drug Reaction All noxious and unintended responses to a medicinal
(ADR) product related to any dose
E6(R1) 1 Glossary of terms
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
Adverse Event (AE)
treatment--any unfavorable and unintended sign ,
symptom, or disease temporally associated with the
use of a medicinal product, whether or not related to
the medicinal product
Applicable Regulatory Any law(s) and regulation(s) addressing the conduct
Requirements of clinical trials of investigational products
The affirmative decision of the IRB that the clinical trial
has been reviewed and may be conducted at the
Institutional Review Board
institution site within the constraints set forth by the
Approval
IRB, the institution, Good Clinical Practice (GCP), and
the applicable regulatory requirements
https://quizlet.com/1089420997/ich-gcp-for-ccrc-exam-prep2025-update-complete-frequently-tested-questions-with-verified-answersget-it-100-accura… 1/14
, 10/8/25, 8:31 AM ICH GCP for CCRC Exam Prep|2025 UPDATE| COMPLETE FREQUENTLY TESTED QUESTIONS WITH VERIFIED ANSWERS|G…
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, analyzed
Audit
and accurately reported according to the protocol,
sponsor's standard operating procedures, (SOPs),
Good Clinical Practice (GCP), and the applicable
regulatory requirement(s)
A declaration of confirmation by the auditor that an
Audit Certificate
audit has taken place
A written evaluation by the sponsor's auditor of the
Audit Report
results of the audit
Documentation that allows reconstruction of the
Audit Trail
course of events
A procedure in which one or more parties to the trial
Blinding/Masking
are kept unaware of the treatment assignment(s).
A printed, optical, or electronic document designed
Case Report Form (CRF) to record all of the protocol required information to
be reported to the sponsor on each trial subject.
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
Clinical Trial/Study
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
A written description of a trial/study of any
therapeutic, prophylactic, or diagnostic agent
Clinical Trial/Study Report conducted in human subjects, in which the clinical and
statistical description, presentations, and analyses are
fully integrated into a single report
https://quizlet.com/1089420997/ich-gcp-for-ccrc-exam-prep2025-update-complete-frequently-tested-questions-with-verified-answersget-it-100-accura… 2/14
