ICH GCP for CCRC Exam Prep| 543
QUESTIONS| COMPLETE SOLUTION
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.
Investigator Correct Answer: A person responsible for the conduct of the clinical trial at a trial
site.
Investigator's Brochure Correct Answer: 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 Correct Answer: 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 Correct Answer: 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 Correct Answer: 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 Correct Answer: 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 Correct Answer: Biomedical studies not performed on human subjects
IEC Opinion Correct Answer: The judgement and/or the advice provided by an Independent
Ethics Committee (IEC)
Protocol Correct Answer: A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
Protocol Amendment Correct Answer: A written description of a change to or formal
clarification of a protocol.
Quality Assurance (QA) Correct Answer: 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) Correct Answer: 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
QUESTIONS| COMPLETE SOLUTION
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.
Investigator Correct Answer: A person responsible for the conduct of the clinical trial at a trial
site.
Investigator's Brochure Correct Answer: 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 Correct Answer: 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 Correct Answer: 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 Correct Answer: 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 Correct Answer: 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 Correct Answer: Biomedical studies not performed on human subjects
IEC Opinion Correct Answer: The judgement and/or the advice provided by an Independent
Ethics Committee (IEC)
Protocol Correct Answer: A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
Protocol Amendment Correct Answer: A written description of a change to or formal
clarification of a protocol.
Quality Assurance (QA) Correct Answer: 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) Correct Answer: 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
