Exam (elaborations)
GOOD CLINICAL PRACTICE ICH EXAM QUESTIONS AND ANSWERS
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GOOD CLINICAL PRACTICE ICH EXAM QUESTIONS AND ANSWERS...
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What constitutes Good Clinical Practice (GCP)? - ANSWER An internationalethical and scientific quality standard for planning, performing, recording, and
reporting studies with human participants.
subjects
What does good clinical practice ensure? - ANSWER Assurance that trial
subjects' rights, safety, and well-being are respected by the principles
underlying the Declaration of Helsinki and that clinical trial data are reliable.
What is the goal of the Good Clinical Practice Guideline? - ANSWER Provide a
common standard for the European Union.
(EU), Japan and the United States to facilitate mutual recognition of clinical
data by their respective regulatory agencies.
Who established the Good Clinical Practice Guideline? - Respondents include
the European Union, Japan, and the United States, as well as Australia, Canada,
the Nordic countries, and the World Health Organization (WHO).
When should the Good Clinical Practice Guideline be followed? - ANSWER
When generating clinical trial data for submission to regulatory bodies.
It can also be applied to other clinical studies that
may affect the safety and well-being of human subjects.
What is an Adverse Drug Reaction (ADR)? - ANSWER All adverse and
unanticipated reactions to a pharmaceutical substance at any dose.
, A causal link between a pharmaceutical substance and an undesirable event.
Adverse drug reaction (ADR) of marketed medicinal products: - ANSWER A
ANSWER to a medicine that is noxious and undesired and that happens at
levels commonly used in man for prophylaxis, diagnosis, or therapy of diseases
or to modify physiological function.
Applicable regulatory requirement(s): - ANSWER Any law(s) or regulations
governing the conduct of clinical studies for investigational items.
Approval (to Institutional Review Boards) - ANSWER The positive decision of
the IRB that the clinical trial has been reviewed and may be undertaken at the
institution.
Audit: A systematic and unbiased evaluation of trial-related actions and records.
Audit Certificate - ANSWER A declaration from the auditor confirming that an
audit was conducted.
The audit report is a written appraisal of the audit results by the sponsor's
auditor.
Blinding/Masking - ANSWER One or more trial participants are kept
uninformed of the treatment assignment(s).
Single-blinding usually means that the subject(s) are oblivious.
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