Exam (elaborations)
GOOD CLINICAL PRACTICE ICH EXAM QUESTIONS AND ANSWERS
- Course
- Institution
GOOD CLINICAL PRACTICE ICH EXAM QUESTIONS AND ANSWERS...
[Show more]
Seller
Follow
Content preview
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.
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Humat. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
78075 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now