10/06/2025, 13:01 ICH GCP for CCRC Exam COMPREHENSIVE QUESTIONS AND VERIFIED ANSWERS (2025) ALREADY GRADED A+ Flashcar…
ICH GCP for CCRC Exam COMPREHENSIVE
QUESTIONS AND VERIFIED ANSWERS (2025)
ALREADY GRADED A+
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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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,10/06/2025, 13:01 ICH GCP for CCRC Exam COMPREHENSIVE QUESTIONS AND VERIFIED ANSWERS (2025) ALREADY GRADED A+ Flashcar…
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
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,10/06/2025, 13:01 ICH GCP for CCRC Exam COMPREHENSIVE QUESTIONS AND VERIFIED ANSWERS (2025) ALREADY GRADED A+ Flashcar…
An investigational or marketed product, or placebo,
Comparator (Product)
used as a reference in a clinical trial.
Adherence to all the trial-related requirements, Good
Compliance to Trials Clinical Practice (GCP) requirements, and the
applicable regulatory requirements
Prevention of disclosure, to other than authorized
Confidentiality individuals, of a sponsor's proprietary information or
of a subject's identity.
A written, dated, and signed agreement between two
or more involved parties that sets out any
Contract arrangements on delegation and distribution of tasks
and obligations and, if appropriate, on financial
matters.
A committee that a sponsor may organize to
Coordinating Committee
coordinate the conduct of a multicenter trial.
An investigator assigned the responsibility for the
Coordinating Ivestigator coordination of investigators at different centers
participating in a multicenter trial
A person or an organization (commercial, academic,
Contract Research or other) contracted by the sponsor to perform one
Organization (CRO) or more of a sponsor's trial-related duties and
functions.
Permission to examine, analyze, verify, and reproduce
Direct Access any records and reports that are important to
evaluation of a clinical trial
All records, in any form that describe or record the
Documentation methods, conduct, and/or results of a trial, the factors
affecting a trial, and the actions taken
Documents which individually and collectively permit
Essential Documents evaluation of the conduct of a study and the quality of
the data produced
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, 10/06/2025, 13:01 ICH GCP for CCRC Exam COMPREHENSIVE QUESTIONS AND VERIFIED ANSWERS (2025) ALREADY GRADED A+ Flashcar…
A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
Good Clinical Practice reporting of clinical trials that provides assurance that
(GCP) the data and reported results are credible and
accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected
Independent Data- An independent data-monitoring committee that may
Monitoring Committee be established by the sponsor to assess at intervals
(IDMC) (Data and Safety the progress of a clinical trial, the safety data, and the
Monitoring Board, critical efficacy endpoints, and to recommend to the
Monitoring Committee, sponsor whether to continue, modify, or stop a trial
Data Monitoring
Committee)
A person, who is independent of the trial, who cannot
be unfairly influenced by people involved with the
trial, who attends the informed consent process if the
Impartial Witness subject or the subject's legally acceptable
representative cannot read, and who reads the
informed consent form and any other written
information supplied to the subject
An independent body constituted of medical
professionals and non-medical members, whose
responsibility it is to ensure the protection of the
rights, safety and well-being of human subjects
involved in a trial and to provide public assurance of
Independent Ethics
that protection, by, among other things, reviewing and
Committee (IEC)
approving / providing favorable opinion on, the trial
protocol, the suitability of the investigator(s), facilities,
and the methods and material to be used in obtaining
and documenting informed consent of the trial
subjects.
https://quizlet.com/1053034123/ich-gcp-for-ccrc-exam-comprehensive-questions-and-verified-answers-2025-already-graded-a-flash-cards/?new 4/83
ICH GCP for CCRC Exam COMPREHENSIVE
QUESTIONS AND VERIFIED ANSWERS (2025)
ALREADY GRADED A+
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/1053034123/ich-gcp-for-ccrc-exam-comprehensive-questions-and-verified-answers-2025-already-graded-a-flash-cards/?new 1/83
,10/06/2025, 13:01 ICH GCP for CCRC Exam COMPREHENSIVE QUESTIONS AND VERIFIED ANSWERS (2025) ALREADY GRADED A+ Flashcar…
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/1053034123/ich-gcp-for-ccrc-exam-comprehensive-questions-and-verified-answers-2025-already-graded-a-flash-cards/?new 2/83
,10/06/2025, 13:01 ICH GCP for CCRC Exam COMPREHENSIVE QUESTIONS AND VERIFIED ANSWERS (2025) ALREADY GRADED A+ Flashcar…
An investigational or marketed product, or placebo,
Comparator (Product)
used as a reference in a clinical trial.
Adherence to all the trial-related requirements, Good
Compliance to Trials Clinical Practice (GCP) requirements, and the
applicable regulatory requirements
Prevention of disclosure, to other than authorized
Confidentiality individuals, of a sponsor's proprietary information or
of a subject's identity.
A written, dated, and signed agreement between two
or more involved parties that sets out any
Contract arrangements on delegation and distribution of tasks
and obligations and, if appropriate, on financial
matters.
A committee that a sponsor may organize to
Coordinating Committee
coordinate the conduct of a multicenter trial.
An investigator assigned the responsibility for the
Coordinating Ivestigator coordination of investigators at different centers
participating in a multicenter trial
A person or an organization (commercial, academic,
Contract Research or other) contracted by the sponsor to perform one
Organization (CRO) or more of a sponsor's trial-related duties and
functions.
Permission to examine, analyze, verify, and reproduce
Direct Access any records and reports that are important to
evaluation of a clinical trial
All records, in any form that describe or record the
Documentation methods, conduct, and/or results of a trial, the factors
affecting a trial, and the actions taken
Documents which individually and collectively permit
Essential Documents evaluation of the conduct of a study and the quality of
the data produced
https://quizlet.com/1053034123/ich-gcp-for-ccrc-exam-comprehensive-questions-and-verified-answers-2025-already-graded-a-flash-cards/?new 3/83
, 10/06/2025, 13:01 ICH GCP for CCRC Exam COMPREHENSIVE QUESTIONS AND VERIFIED ANSWERS (2025) ALREADY GRADED A+ Flashcar…
A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
Good Clinical Practice reporting of clinical trials that provides assurance that
(GCP) the data and reported results are credible and
accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected
Independent Data- An independent data-monitoring committee that may
Monitoring Committee be established by the sponsor to assess at intervals
(IDMC) (Data and Safety the progress of a clinical trial, the safety data, and the
Monitoring Board, critical efficacy endpoints, and to recommend to the
Monitoring Committee, sponsor whether to continue, modify, or stop a trial
Data Monitoring
Committee)
A person, who is independent of the trial, who cannot
be unfairly influenced by people involved with the
trial, who attends the informed consent process if the
Impartial Witness subject or the subject's legally acceptable
representative cannot read, and who reads the
informed consent form and any other written
information supplied to the subject
An independent body constituted of medical
professionals and non-medical members, whose
responsibility it is to ensure the protection of the
rights, safety and well-being of human subjects
involved in a trial and to provide public assurance of
Independent Ethics
that protection, by, among other things, reviewing and
Committee (IEC)
approving / providing favorable opinion on, the trial
protocol, the suitability of the investigator(s), facilities,
and the methods and material to be used in obtaining
and documenting informed consent of the trial
subjects.
https://quizlet.com/1053034123/ich-gcp-for-ccrc-exam-comprehensive-questions-and-verified-answers-2025-already-graded-a-flash-cards/?new 4/83
