ACRP-CP Exam Review
ACCURATE 100%
Adverse Drug Reaction (ADR) - ANSWER All noxious and unintended responses to a medicinal product
related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed
medicinal products: a response to a drug which is noxious and unintended and which occurs at doses
normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of
physiological function
Adverse Event (AE) - 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. (ICH GCP E6 1.2)
Audit - 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 Trail - ANSWER Documentation that allows reconstruction of the course of events.
Blinding/Masking - ANSWER A procedure in which one or more parties to the trial are kept unaware of
the treatment assignment. Single-blinding usually refers to the subject(s) being unaware, and double-
blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being
unaware of the treatment assignment(s). (ICH GCP E6 1.10)
Case Report Form (CRF) - 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 - 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 - 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 analysis are fully integrated into a single report. (ICH GCP E6 1.13)
contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the
regulatory authority(ies).
Institutional Review Board (IRB) - 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.
Investigational Product - 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 - ANSWER A person responsible for the conduct of the clinical trial at a trial site. If a trial is
conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team
and may be called the principal investigator.
Investigator's Brochure - 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 - 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 - 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).
