ACRP CCRC Exam Prep (135 Questions) 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
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
