ACRP CCRC EXAM PREP| 135 questions|
WITH COMPLETE SOLUTION
Adverse Drug Reaction (ADR) Correct Answer: 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) 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.
Applicable Regulatory Requirement(s) Correct Answer: Any law(s) and regulation(s) addressing
the conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) 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).
Single-blinding Correct Answer: usually refers to the subject(s) being unaware
Double- blinding Correct Answer: 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) 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 (i.e., active
control), or placebo, used as a reference in a clinical trial.
Compliance (in relation 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 multicentre trial.
Coordinating Investigator Correct Answer: An investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre 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 (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 Correct Answer: Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced
WITH COMPLETE SOLUTION
Adverse Drug Reaction (ADR) Correct Answer: 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) 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.
Applicable Regulatory Requirement(s) Correct Answer: Any law(s) and regulation(s) addressing
the conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) 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).
Single-blinding Correct Answer: usually refers to the subject(s) being unaware
Double- blinding Correct Answer: 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) 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 (i.e., active
control), or placebo, used as a reference in a clinical trial.
Compliance (in relation 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 multicentre trial.
Coordinating Investigator Correct Answer: An investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre 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 (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 Correct Answer: Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced
