ICH GCP for CCRC Exam Prep|543 Questions and
Answers 2023 Graded A+.
Adverse Drug Reaction (ADR)
All noxious and unintended responses to a medicinal product related to any dose
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Glossary of terms
Adverse Event (AE)
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
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.
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 and Safety Monitoring
Board, Monitoring Committee, Data Monitoring Committee)
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
,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.
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.
Regulatory Authorities
Bodies having the power to regulate.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
Any untoward medical occurrence that at any dose:
-results in death
-is life-threatening
-requires inpatient hospitalization or prolongation of existing hospitalization
-results in persistent or significant disability/incapacity
-is a congenital anomaly/birth defect
Source Data
All information in original records and certified copies of original records of clinical
findings, observations, or other activities in a clinical trial necessary for the
reconstruction and evaluation of the trial
Source Documents
