ICH GCP for CCRC Exam Prep
Adverse Drug Reaction (ADR) - ANS -All noxious and unintended responses to a
medicinal product related to any dose
E6(R1) 1 - ANS -Glossary of terms
Adverse Event (AE) - ANS -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--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 Requirements - ANS -Any law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products
Institutional Review Board Approval - ANS -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 - ANS -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 - ANS -A declaration of confirmation by the auditor that an audit has
taken place
Audit Report - ANS -A written evaluation by the sponsor's auditor of the results of the
audit
Audit Trail - ANS -Documentation that allows reconstruction of the course of events
Blinding/Masking - ANS -A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment(s).
,Case Report Form (CRF) - ANS -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 - ANS -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 - ANS -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) - ANS -An investigational or marketed product, or placebo, used
as a reference in a clinical trial.
Compliance to Trials - ANS -Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements
Confidentiality - ANS -Prevention of disclosure, to other than authorized individuals, of a
sponsor's proprietary information or of a subject's identity.
Contract - ANS -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 - ANS -A committee that a sponsor may organize to coordinate
the conduct of a multicenter trial.
Coordinating Ivestigator - ANS -An investigator assigned the responsibility for the
coordination of investigators at different centers participating in a multicenter trial
Contract Research Organization (CRO) - ANS -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 - ANS -Permission to examine, analyze, verify, and reproduce any records
and reports that are important to evaluation of a clinical trial
Documentation - ANS -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 - ANS -Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced
Good Clinical Practice (GCP) - ANS -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 and Safety Monitoring Board,
Monitoring Committee, Data Monitoring Committee) - ANS -An independent
data-monitoring committee that may be established by the sponsor to assess at intervals
the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to
recommend to the sponsor whether to continue, modify, or stop a trial
Impartial Witness - ANS -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) - ANS -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 - ANS -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 - ANS -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) - ANS -Any public or private entity or agency or medical or dental
facility where clinical trials are conducted
Institutional Review Board (IRB) - ANS -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 - ANS -A report of intermediate results and their
evaluation based on analyses performed during the course of a trial
Investigational Product - ANS -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.
Investigator - ANS -A person responsible for the conduct of the clinical trial at a trial site.
Investigator's Brochure - ANS -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 - ANS -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 - ANS -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 - ANS -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 - ANS -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 - ANS -Biomedical studies not performed on human subjects
IEC Opinion - ANS -The judgement and/or the advice provided by an Independent Ethics
Committee (IEC)
Protocol - ANS -A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
Adverse Drug Reaction (ADR) - ANS -All noxious and unintended responses to a
medicinal product related to any dose
E6(R1) 1 - ANS -Glossary of terms
Adverse Event (AE) - ANS -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--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 Requirements - ANS -Any law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products
Institutional Review Board Approval - ANS -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 - ANS -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 - ANS -A declaration of confirmation by the auditor that an audit has
taken place
Audit Report - ANS -A written evaluation by the sponsor's auditor of the results of the
audit
Audit Trail - ANS -Documentation that allows reconstruction of the course of events
Blinding/Masking - ANS -A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment(s).
,Case Report Form (CRF) - ANS -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 - ANS -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 - ANS -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) - ANS -An investigational or marketed product, or placebo, used
as a reference in a clinical trial.
Compliance to Trials - ANS -Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements
Confidentiality - ANS -Prevention of disclosure, to other than authorized individuals, of a
sponsor's proprietary information or of a subject's identity.
Contract - ANS -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 - ANS -A committee that a sponsor may organize to coordinate
the conduct of a multicenter trial.
Coordinating Ivestigator - ANS -An investigator assigned the responsibility for the
coordination of investigators at different centers participating in a multicenter trial
Contract Research Organization (CRO) - ANS -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 - ANS -Permission to examine, analyze, verify, and reproduce any records
and reports that are important to evaluation of a clinical trial
Documentation - ANS -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 - ANS -Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced
Good Clinical Practice (GCP) - ANS -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 and Safety Monitoring Board,
Monitoring Committee, Data Monitoring Committee) - ANS -An independent
data-monitoring committee that may be established by the sponsor to assess at intervals
the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to
recommend to the sponsor whether to continue, modify, or stop a trial
Impartial Witness - ANS -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) - ANS -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 - ANS -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 - ANS -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) - ANS -Any public or private entity or agency or medical or dental
facility where clinical trials are conducted
Institutional Review Board (IRB) - ANS -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 - ANS -A report of intermediate results and their
evaluation based on analyses performed during the course of a trial
Investigational Product - ANS -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.
Investigator - ANS -A person responsible for the conduct of the clinical trial at a trial site.
Investigator's Brochure - ANS -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 - ANS -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 - ANS -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 - ANS -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 - ANS -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 - ANS -Biomedical studies not performed on human subjects
IEC Opinion - ANS -The judgement and/or the advice provided by an Independent Ethics
Committee (IEC)
Protocol - ANS -A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
