ICH GCP FOR CCRC EXAM PREP QUESTIONS AND
ANSWERS
Adverse Drug Reaction (ADR) - CORRECT ANSWER✅✅All noxious and unintended responses to a
medicinal product related to any dose
E6(R1) 1 - CORRECT ANSWER✅✅Glossary of terms
Adverse Event (AE) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅Any law(s) and regulation(s) addressing
the conduct of clinical trials of investigational products
Institutional Review Board Approval - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅A declaration of confirmation by the auditor that an audit has
taken place
Audit Report - CORRECT ANSWER✅✅A written evaluation by the sponsor's auditor of the results of the
audit
,Audit Trail - CORRECT ANSWER✅✅Documentation that allows reconstruction of the course of events
Blinding/Masking - CORRECT ANSWER✅✅A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment(s).
Case Report Form (CRF) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅An investigational or marketed product, or placebo, used
as a reference in a clinical trial.
Compliance to Trials - CORRECT ANSWER✅✅Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements
Confidentiality - CORRECT ANSWER✅✅Prevention of disclosure, to other than authorized individuals, of
a sponsor's proprietary information or of a subject's identity.
Contract - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅A committee that a sponsor may organize to
coordinate the conduct of a multicenter trial.
,Coordinating Ivestigator - CORRECT ANSWER✅✅An investigator assigned the responsibility for the
coordination of investigators at different centers participating in a multicenter trial
Contract Research Organization (CRO) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial
Documentation - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced
Good Clinical Practice (GCP) - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅Any public or private entity or agency or medical or dental
facility where clinical trials are conducted
Institutional Review Board (IRB) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅A report of intermediate results and their
evaluation based on analyses performed during the course of a trial
Investigational Product - CORRECT ANSWER✅✅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.
ANSWERS
Adverse Drug Reaction (ADR) - CORRECT ANSWER✅✅All noxious and unintended responses to a
medicinal product related to any dose
E6(R1) 1 - CORRECT ANSWER✅✅Glossary of terms
Adverse Event (AE) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅Any law(s) and regulation(s) addressing
the conduct of clinical trials of investigational products
Institutional Review Board Approval - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅A declaration of confirmation by the auditor that an audit has
taken place
Audit Report - CORRECT ANSWER✅✅A written evaluation by the sponsor's auditor of the results of the
audit
,Audit Trail - CORRECT ANSWER✅✅Documentation that allows reconstruction of the course of events
Blinding/Masking - CORRECT ANSWER✅✅A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment(s).
Case Report Form (CRF) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅An investigational or marketed product, or placebo, used
as a reference in a clinical trial.
Compliance to Trials - CORRECT ANSWER✅✅Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements
Confidentiality - CORRECT ANSWER✅✅Prevention of disclosure, to other than authorized individuals, of
a sponsor's proprietary information or of a subject's identity.
Contract - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅A committee that a sponsor may organize to
coordinate the conduct of a multicenter trial.
,Coordinating Ivestigator - CORRECT ANSWER✅✅An investigator assigned the responsibility for the
coordination of investigators at different centers participating in a multicenter trial
Contract Research Organization (CRO) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial
Documentation - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced
Good Clinical Practice (GCP) - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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) - CORRECT ANSWER✅✅Any public or private entity or agency or medical or dental
facility where clinical trials are conducted
Institutional Review Board (IRB) - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅A report of intermediate results and their
evaluation based on analyses performed during the course of a trial
Investigational Product - CORRECT ANSWER✅✅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.
