Exam (elaborations)
GOOD CLINICAL PRACTICE (GCP) JDS EXAM QUESTIONS AND ANSWERS
- Course
- Institution
GOOD CLINICAL PRACTICE (GCP) JDS EXAM QUESTIONS AND ANSWERS...
[Show more]
Seller
Follow
Content preview
What makes GCP significant? - ANSWER The public is reassured by GCPcompliance that the safety, rights, and welfare of study participants are
safeguarded.
What are GCP's objectives? - ANSWER 1. To safeguard the welfare, safety,
and rights of research participants
2. To guarantee the integrity, dependability, and quality of the data gathered
3. To establish norms and regulations for clinical research conduct
4. Quality Data + Ethics = Good Clinical Practice
Which principles underpin the moral conduct of clinical research? The
Nuremberg Code (1947) is the first ANSWER.
2. The 1964 Helsinki Declaration
3. The 1979 Belmont Report
4. ICH-GCP, the International Conference on
Harmonization
5. Organization for International Standards 14155
, 6. Federal Regulations Code
The answer to the Nuremberg Code (1947) is voluntary participation.
- Knowledgeable Consent
Reduction of danger
Declaration of Helsinki (1964): ANSWER: The subject's welfare comes first
Respect for individuals
Protection of the rights and health of the subjects
Particular safeguards for populations that are at risk
Respect for Persons is the ANSWER to the Belmont Report's Ethical Principles
(1979).
• Consent that is informed
• Safeguarding populations that are at risk
- Goodness
• Non-malfeasance
Fairness
• Equitable
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)
77858 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now