ACRP-CP Exam Review 2023 Based on Declaration of
Helsinki and ICH E2A, E6_R2, E8, E9, E11 with complete
solution
Adverse Drug Reaction (ADR)
In the pre-approval clinical experience with a new medicinal product or its new usages,
particularly as the therapeutic dose(s) may not be established: all noxious and
unintended responses to a medicinal product related to any dose should be considered
adverse drug reactions.
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.
Applicable Regulatory Requirement(s)
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational
products.
Approval (in relation to Institutional Review Boards)
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).
Single-blinding
usually refers to the subject(s) being unaware
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).
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 (i.e., active control), or placebo, used as a
reference in a clinical trial.
Compliance (in relation 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 multicentre
trial.
Coordinating Investigator
An investigator assigned the responsibility for the coordination of investigators at
different centres participating in a multicentre 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 (including, but not limited to, written, electronic, magnetic, and
optical records, and scans, x-rays, and electrocardiograms) 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
Helsinki and ICH E2A, E6_R2, E8, E9, E11 with complete
solution
Adverse Drug Reaction (ADR)
In the pre-approval clinical experience with a new medicinal product or its new usages,
particularly as the therapeutic dose(s) may not be established: all noxious and
unintended responses to a medicinal product related to any dose should be considered
adverse drug reactions.
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.
Applicable Regulatory Requirement(s)
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational
products.
Approval (in relation to Institutional Review Boards)
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).
Single-blinding
usually refers to the subject(s) being unaware
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).
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 (i.e., active control), or placebo, used as a
reference in a clinical trial.
Compliance (in relation 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 multicentre
trial.
Coordinating Investigator
An investigator assigned the responsibility for the coordination of investigators at
different centres participating in a multicentre 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 (including, but not limited to, written, electronic, magnetic, and
optical records, and scans, x-rays, and electrocardiograms) 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
