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ICH GCP for CCRC Exam Prep questions with correct answers
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ICH GCP for CCRC Exam Prep questions with correct answers
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ICH GCP for CCRC Exam Prep questionswith correct answers
Adverse Drug Reaction (ADR) - ** VERIFIED ANSWERS **✔✔All noxious and unintended
responses to a medicinal product related to any dose
E6(R1) 1 - ** VERIFIED ANSWERS **✔✔Glossary of terms
Adverse Event (AE) - ** VERIFIED ANSWERS **✔✔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--any unfavorable and unintended sign ,
symptom, or disease temporally associated with the use of a medicinal product, whether or not
related to the medicinal product
Applicable Regulatory Requirements - ** VERIFIED ANSWERS **✔✔Any law(s) and regulation(s)
addressing the conduct of clinical trials of investigational products
Institutional Review Board Approval - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔A declaration of confirmation by the auditor that
an audit has taken place
,Audit Report - ** VERIFIED ANSWERS **✔✔A written evaluation by the sponsor's auditor of the
results of the audit
Audit Trail - ** VERIFIED ANSWERS **✔✔Documentation that allows reconstruction of the course
of events
Blinding/Masking - ** VERIFIED ANSWERS **✔✔A procedure in which one or more parties to the
trial are kept unaware of the treatment assignment(s).
Case Report Form (CRF) - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔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) - ** VERIFIED ANSWERS **✔✔An investigational or marketed product, or
placebo, used as a reference in a clinical trial.
Compliance to Trials - ** VERIFIED ANSWERS **✔✔Adherence to all the trial-related
requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory
requirements
Confidentiality - ** VERIFIED ANSWERS **✔✔Prevention of disclosure, to other than authorized
individuals, of a sponsor's proprietary information or of a subject's identity.
,Contract - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔A committee that a sponsor may organize
to coordinate the conduct of a multicenter trial.
Coordinating Ivestigator - ** VERIFIED ANSWERS **✔✔An investigator assigned the responsibility
for the coordination of investigators at different centers participating in a multicenter trial
Contract Research Organization (CRO) - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a clinical trial
Documentation - ** VERIFIED ANSWERS **✔✔All records, in any form that describe or record the
methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken
Essential Documents - ** VERIFIED ANSWERS **✔✔Documents which individually and
collectively permit evaluation of the conduct of a study and the quality of the data produced
Good Clinical Practice (GCP) - ** VERIFIED ANSWERS **✔✔A standard for the design, conduct,
performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides
assurance that the data and reported results are credible and accurate, and that the rights, integrity,
and confidentiality of trial subjects are protected
Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring
Committee, Data Monitoring Committee) - ** VERIFIED ANSWERS **✔✔An independent data-
monitoring committee that may be established by the sponsor to assess at intervals the progress of a
clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor
whether to continue, modify, or stop a trial
, Impartial Witness - ** VERIFIED ANSWERS **✔✔A person, who is independent of the trial, who
cannot be unfairly influenced by people involved with the trial, who attends the informed consent
process if the subject or the subject's legally acceptable representative cannot read, and who reads
the informed consent form and any other written information supplied to the subject
Independent Ethics Committee (IEC) - ** VERIFIED ANSWERS **✔✔An independent body
constituted of medical professionals and non-medical members, whose responsibility it is to ensure
the protection of the rights, safety and well-being of human subjects involved in a trial and to
provide public assurance of that protection, by, among other things, reviewing and approving /
providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and
the methods and material to be used in obtaining and documenting informed consent of the trial
subjects.
Informed Consent - ** VERIFIED ANSWERS **✔✔A process by which a subject voluntarily
confirms his or her willingness to participate in a particular trial, after having been informed of all
aspects of the trial that are relevant to the subject's decision to participate--documented by means of
a written, signed and dated informed consent form
Inspection - ** VERIFIED ANSWERS **✔✔The act by a regulatory authority of conducting an
official review of documents, facilities, records, and any other resources that are deemed by the
authorities to be related to the clinical trial and that may be located at the site of the trial, at the
sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments
deemed appropriate by the regulatory authorities
Institution (Medical) - ** VERIFIED ANSWERS **✔✔Any public or private entity or agency or
medical or dental facility where clinical trials are conducted
Institutional Review Board (IRB) - ** VERIFIED ANSWERS **✔✔An independent body constituted
of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of
the rights, safety, and well-being of human subjects involved in a trial by, among other things,
reviewing, approving, and providing continuing review of trial protocol and amendments and of the
methods and material to be used in obtaining and documenting informed consent of the trial
subjects
Interim Clinical Trial/Study Report - ** VERIFIED ANSWERS **✔✔A report of intermediate results
and their evaluation based on analyses performed during the course of a trial
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