9/30/25, 8:35 PM ICH GCP for CCRC Exam Prep
ICH GCP for CCRC Exam Prep Comprehensive NEWEST
EXAM 2025-2026 \LATEST VERSION WITH COMPLETE
200 QUESTIONS AND ACCURATE DETAILED ANSWERS
\VERIFIED ANSWERS \ALREADY GRADED A+
Adverse Drug Reaction (ADR) All noxious and unintended responses to a medicinal product
related to any dose
E6(R1) 1 Glossary of terms
Any untoward medical occurrence in a patient or
clinical investigation subject administered a
Adverse Event (AE) pharmaceutical product and which does not necessarily
have a causal relationship with this 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
Any law(s) and regulation(s) addressing the conduct of
Applicable Regulatory
Requirements clinical trials of investigational products
The affirmative decision of the IRB that the clinical trial
Institutional Review Board has been reviewed and may be conducted at the
Approval
institution site within the constraints set forth by the
IRB, the institution, Good Clinical Practice (GCP), and
the applicable regulatory requirements
A systematic and independent examination of trial
related activities and documents to determine whether
Audit the evaluated trial related activities were conducted,
and the data were recorded, analyzed and
accurately reported according to the protocol,
sponsor's standard operating procedures, (SOPs), Good
Clinical Practice (GCP), and the applicable regulatory
requirement(s)
Audit Certificate A declaration of confirmation by the auditor that an audit has
taken place
1/81
,9/30/25, 8:35 PM ICH GCP for CCRC Exam Prep
Audit Report A written evaluation by the sponsor's auditor of the results of the
audit
Audit Trail Documentation that allows reconstruction of the course of events
A procedure in which one or more parties to the trial are
Blinding/Masking
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
Clinical Trial/Study
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
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
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.
2/81
,9/30/25, 8:35 PM ICH GCP for CCRC Exam Prep
A written, dated, and signed agreement between two or
Contract more involved parties that sets out any arrangements
on delegation and distribution of tasks and obligations
and, if appropriate, on financial matters.
A committee that a sponsor may organize to coordinate
Coordinating Committee
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, or
Contract Research
Organization (CRO) other) contracted by the sponsor to perform one 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
A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting
Good Clinical Practice (GCP)
of clinical trials that provides assurance that 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 the
(IDMC) (Data and Safety progress of a clinical trial, the safety data, and the
Monitoring Board, Monitoring critical
Committee, Data efficacy endpoints, and to recommend to the sponsor
Monitoring Committee) whether to continue, modify, or stop a trial
3/81
, 9/30/25, 8:35 PM ICH GCP for CCRC Exam Prep
A person, who is independent of the trial, who
cannot be unfairly influenced by people involved
Impartial Witness with the trial, who attends the informed consent
process if the 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
Independent Ethics
Committee (IEC) subjects involved in a trial and to provide public
assurance of that protection, by, among other things,
reviewing and 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.
4/81
ICH GCP for CCRC Exam Prep Comprehensive NEWEST
EXAM 2025-2026 \LATEST VERSION WITH COMPLETE
200 QUESTIONS AND ACCURATE DETAILED ANSWERS
\VERIFIED ANSWERS \ALREADY GRADED A+
Adverse Drug Reaction (ADR) All noxious and unintended responses to a medicinal product
related to any dose
E6(R1) 1 Glossary of terms
Any untoward medical occurrence in a patient or
clinical investigation subject administered a
Adverse Event (AE) pharmaceutical product and which does not necessarily
have a causal relationship with this 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
Any law(s) and regulation(s) addressing the conduct of
Applicable Regulatory
Requirements clinical trials of investigational products
The affirmative decision of the IRB that the clinical trial
Institutional Review Board has been reviewed and may be conducted at the
Approval
institution site within the constraints set forth by the
IRB, the institution, Good Clinical Practice (GCP), and
the applicable regulatory requirements
A systematic and independent examination of trial
related activities and documents to determine whether
Audit the evaluated trial related activities were conducted,
and the data were recorded, analyzed and
accurately reported according to the protocol,
sponsor's standard operating procedures, (SOPs), Good
Clinical Practice (GCP), and the applicable regulatory
requirement(s)
Audit Certificate A declaration of confirmation by the auditor that an audit has
taken place
1/81
,9/30/25, 8:35 PM ICH GCP for CCRC Exam Prep
Audit Report A written evaluation by the sponsor's auditor of the results of the
audit
Audit Trail Documentation that allows reconstruction of the course of events
A procedure in which one or more parties to the trial are
Blinding/Masking
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
Clinical Trial/Study
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
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
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.
2/81
,9/30/25, 8:35 PM ICH GCP for CCRC Exam Prep
A written, dated, and signed agreement between two or
Contract more involved parties that sets out any arrangements
on delegation and distribution of tasks and obligations
and, if appropriate, on financial matters.
A committee that a sponsor may organize to coordinate
Coordinating Committee
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, or
Contract Research
Organization (CRO) other) contracted by the sponsor to perform one 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
A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting
Good Clinical Practice (GCP)
of clinical trials that provides assurance that 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 the
(IDMC) (Data and Safety progress of a clinical trial, the safety data, and the
Monitoring Board, Monitoring critical
Committee, Data efficacy endpoints, and to recommend to the sponsor
Monitoring Committee) whether to continue, modify, or stop a trial
3/81
, 9/30/25, 8:35 PM ICH GCP for CCRC Exam Prep
A person, who is independent of the trial, who
cannot be unfairly influenced by people involved
Impartial Witness with the trial, who attends the informed consent
process if the 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
Independent Ethics
Committee (IEC) subjects involved in a trial and to provide public
assurance of that protection, by, among other things,
reviewing and 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.
4/81
