ICH GCP for CCRC Exam Prep
Applicable Regulatory Requirements Any law(s) and regulation(s) addressing the conduct of clinical trials of
investigational products
Institutional Review Board Approval 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, Good Clinical Practice (GCP), and the applicable regulatory
requirements
Audit 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 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
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
Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the
treatment assignment(s).
Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol
required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study 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
Clinical Trial/Study Report 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 analyses are fully integrated into a single report
Comparator (Product) An investigational or marketed product, or placebo, used as a reference in a
clinical trial.
Stuvia 2026-2027
, ICH GCP for CCRC Exam Prep
Compliance to Trials Adherence to all the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements
Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor's
proprietary information or of a subject's identity.
Contract 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.
Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a
multicenter trial.
Coordinating Ivestigator An investigator assigned the responsibility for the coordination of investigators at
different centers participating in a multicenter trial
Contract Research Organization (CRO) 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.
Direct Access Permission to examine, analyze, verify, and reproduce any records and reports
that are important to evaluation of a clinical trial
Documentation 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
Essential Documents Documents which individually and collectively permit evaluation of the conduct
of a study and the quality of the data produced
Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting 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-Monitoring Committee (IDMC) (Data An independent data-monitoring committee that may be established by the
and Safety Monitoring Board, Monitoring Committee, sponsor to assess at intervals the progress of a clinical trial, the safety data, and
Data Monitoring Committee) the critical efficacy endpoints, and to recommend to the sponsor whether to
continue, modify, or stop a trial
Stuvia 2026-2027
, ICH GCP for CCRC Exam Prep
Impartial Witness 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
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
Independent Ethics Committee (IEC) 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 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.
Informed Consent A process by which a subject voluntarily confirms his or her willingness to
participate in a particular trial, after having been informed of all aspects of the
trial that are relevant to the subject's decision to participate--documented by
means of a written, signed and dated informed consent form
Inspection The act by a regulatory authority of conducting an official review of documents,
facilities, records, and any other resources that are deemed by the authorities to
be related to the clinical trial and that may be located at the site of the trial, at the
sponsor's and/or contract research organization's (CRO's) facilities, or at other
establishments deemed appropriate by the regulatory authorities
Institution (Medical) Any public or private entity or agency or medical or dental facility where clinical
trials are conducted
Institutional Review Board (IRB) An independent body constituted of medical, scientific, and non-scientific
members, whose responsibility is to ensure the protection of the rights, safety, and
well-being of human subjects involved in a trial by, among other things, reviewing,
approving, and providing continuing review of trial protocol and amendments
and of the methods and material to be used in obtaining and documenting
informed consent of the trial subjects
Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses
performed during the course of a trial
Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as
a reference in a clinical trial, including a product with a marketing authorization
when used or assembled (formulated or packaged) in a way different from the
approved form, or when used for an unapproved indication, or when used to gain
further information about an approved use.
Stuvia 2026-2027
, ICH GCP for CCRC Exam Prep
Investigator A person responsible for the conduct of the clinical trial at a trial site.
Investigator's Brochure A compilation of the clinical and nonclinical data on the investigational product(s)
which is relevant to the study of the investigational product(s) in human subjects.
Legally Acceptable Representative An individual or juridical or other body authorized under applicable law to
consent, on behalf of a prospective subject, to the subject's participation in the
clinical trial.
Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is
conducted, recorded, and reported in accordance with the protocol, Standard
Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).
Monitoring Report A written report from the monitor to the sponsor after each site visit and/or other
trial-related communication according to the sponsor's SOPs.
Multicenter Trial A clinical trial conducted according to a single protocol but at more than one site,
and therefore, carried out by more than one investigator
Nonclinical Study Biomedical studies not performed on human subjects
IEC Opinion The judgement and/or the advice provided by an Independent Ethics Committee
(IEC)
Protocol A document that describes the objective(s), design, methodology, statistical
considerations, and organization of a trial.
Protocol Amendment A written description of a change to or formal clarification of a protocol.
Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the
trial is performed ad the data are generated, documented, and reported in
compliance with GCP and the applicable regulatory requirements
Quality Control (QC) The operational techniques and activities undertaken within the quality assurance
system to verify that the requirements for quality of the trial-related activities have
been fulfilled
Randomization The process of assigning trial subjects to treatment or control groups using an
element of chance to determine the assignments in order to reduce bias.
Stuvia 2026-2027
Applicable Regulatory Requirements Any law(s) and regulation(s) addressing the conduct of clinical trials of
investigational products
Institutional Review Board Approval 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, Good Clinical Practice (GCP), and the applicable regulatory
requirements
Audit 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 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
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
Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the
treatment assignment(s).
Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol
required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study 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
Clinical Trial/Study Report 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 analyses are fully integrated into a single report
Comparator (Product) An investigational or marketed product, or placebo, used as a reference in a
clinical trial.
Stuvia 2026-2027
, ICH GCP for CCRC Exam Prep
Compliance to Trials Adherence to all the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements
Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor's
proprietary information or of a subject's identity.
Contract 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.
Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a
multicenter trial.
Coordinating Ivestigator An investigator assigned the responsibility for the coordination of investigators at
different centers participating in a multicenter trial
Contract Research Organization (CRO) 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.
Direct Access Permission to examine, analyze, verify, and reproduce any records and reports
that are important to evaluation of a clinical trial
Documentation 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
Essential Documents Documents which individually and collectively permit evaluation of the conduct
of a study and the quality of the data produced
Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting 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-Monitoring Committee (IDMC) (Data An independent data-monitoring committee that may be established by the
and Safety Monitoring Board, Monitoring Committee, sponsor to assess at intervals the progress of a clinical trial, the safety data, and
Data Monitoring Committee) the critical efficacy endpoints, and to recommend to the sponsor whether to
continue, modify, or stop a trial
Stuvia 2026-2027
, ICH GCP for CCRC Exam Prep
Impartial Witness 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
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
Independent Ethics Committee (IEC) 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 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.
Informed Consent A process by which a subject voluntarily confirms his or her willingness to
participate in a particular trial, after having been informed of all aspects of the
trial that are relevant to the subject's decision to participate--documented by
means of a written, signed and dated informed consent form
Inspection The act by a regulatory authority of conducting an official review of documents,
facilities, records, and any other resources that are deemed by the authorities to
be related to the clinical trial and that may be located at the site of the trial, at the
sponsor's and/or contract research organization's (CRO's) facilities, or at other
establishments deemed appropriate by the regulatory authorities
Institution (Medical) Any public or private entity or agency or medical or dental facility where clinical
trials are conducted
Institutional Review Board (IRB) An independent body constituted of medical, scientific, and non-scientific
members, whose responsibility is to ensure the protection of the rights, safety, and
well-being of human subjects involved in a trial by, among other things, reviewing,
approving, and providing continuing review of trial protocol and amendments
and of the methods and material to be used in obtaining and documenting
informed consent of the trial subjects
Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses
performed during the course of a trial
Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as
a reference in a clinical trial, including a product with a marketing authorization
when used or assembled (formulated or packaged) in a way different from the
approved form, or when used for an unapproved indication, or when used to gain
further information about an approved use.
Stuvia 2026-2027
, ICH GCP for CCRC Exam Prep
Investigator A person responsible for the conduct of the clinical trial at a trial site.
Investigator's Brochure A compilation of the clinical and nonclinical data on the investigational product(s)
which is relevant to the study of the investigational product(s) in human subjects.
Legally Acceptable Representative An individual or juridical or other body authorized under applicable law to
consent, on behalf of a prospective subject, to the subject's participation in the
clinical trial.
Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is
conducted, recorded, and reported in accordance with the protocol, Standard
Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).
Monitoring Report A written report from the monitor to the sponsor after each site visit and/or other
trial-related communication according to the sponsor's SOPs.
Multicenter Trial A clinical trial conducted according to a single protocol but at more than one site,
and therefore, carried out by more than one investigator
Nonclinical Study Biomedical studies not performed on human subjects
IEC Opinion The judgement and/or the advice provided by an Independent Ethics Committee
(IEC)
Protocol A document that describes the objective(s), design, methodology, statistical
considerations, and organization of a trial.
Protocol Amendment A written description of a change to or formal clarification of a protocol.
Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the
trial is performed ad the data are generated, documented, and reported in
compliance with GCP and the applicable regulatory requirements
Quality Control (QC) The operational techniques and activities undertaken within the quality assurance
system to verify that the requirements for quality of the trial-related activities have
been fulfilled
Randomization The process of assigning trial subjects to treatment or control groups using an
element of chance to determine the assignments in order to reduce bias.
Stuvia 2026-2027
