ACRP CCRC EXAM PREP COMPLETE COURSE
REVIEW GUIDE
◉ 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.
REVIEW GUIDE
◉ 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.
