ACRP CCRC FINAL EXAM 2024 ACTUAL EXAM 300 QUESTIONS
WITH DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS) /ALREADY GRADED A+
Adverse Drug Reaction (ADR) - 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) - 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) - ANSWER: Any law(s) and regulation(s)
addressing the conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) - 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 - 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 - ANSWER: A declaration of confirmation by the auditor that an
audit has taken place.
Audit Report - ANSWER: A written evaluation by the sponsor's auditor of the results
of the audit.
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(s).
Single-blinding - ANSWER: usually refers to the subject(s) being unaware
Double- blinding - 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) - 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 analyses are fully
integrated into a single report
Comparator (Product) - 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) - ANSWER: Adherence to all the trial-related
requirements, Good Clinical Practice (GCP) requirements, and the applicable
regulatory requirements.
Confidentiality - ANSWER: Prevention of disclosure, to other than authorized
individuals, of a sponsor's proprietary information or of a subject's identity.
Contract - 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 - ANSWER: A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial.
Coordinating Investigator - ANSWER: An investigator assigned the responsibility for
the coordination of investigators at different centres participating in a multicentre
trial.
Contract Research Organization (CRO) - 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 - ANSWER: Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.
Documentation - ANSWER: All records, in any form (including, but not limited to,
written, electronic, magnetic, and optical records, and scans, x-rays, and
WITH DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS) /ALREADY GRADED A+
Adverse Drug Reaction (ADR) - 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) - 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) - ANSWER: Any law(s) and regulation(s)
addressing the conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) - 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 - 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 - ANSWER: A declaration of confirmation by the auditor that an
audit has taken place.
Audit Report - ANSWER: A written evaluation by the sponsor's auditor of the results
of the audit.
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(s).
Single-blinding - ANSWER: usually refers to the subject(s) being unaware
Double- blinding - 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) - 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 analyses are fully
integrated into a single report
Comparator (Product) - 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) - ANSWER: Adherence to all the trial-related
requirements, Good Clinical Practice (GCP) requirements, and the applicable
regulatory requirements.
Confidentiality - ANSWER: Prevention of disclosure, to other than authorized
individuals, of a sponsor's proprietary information or of a subject's identity.
Contract - 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 - ANSWER: A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial.
Coordinating Investigator - ANSWER: An investigator assigned the responsibility for
the coordination of investigators at different centres participating in a multicentre
trial.
Contract Research Organization (CRO) - 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 - ANSWER: Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.
Documentation - ANSWER: All records, in any form (including, but not limited to,
written, electronic, magnetic, and optical records, and scans, x-rays, and
