Good Clinical Practice (GCP) - Relationships - The Foundation of Ethics and Science
6 important questions on Good Clinical Practice (GCP) - Relationships - The Foundation of Ethics and Science
The Foundation of Ethics and Science relationship of GCP is comparised of 4 principals. What are these 4 principals?
- Declaration of Helsinki
- Scientific Rigour
- Informed Consent
- External Oversight
Scientific rigour principal of The Foundation of Ethics and Science relationship. what does this principal state?
Every trial must be scientifically sound and described in a clear, detailed protocol
what is the purpose of the informed concent guideline?
ensure the patient understands all aspects of the experiment when deciding to participate in the study
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what is the purpose of the external oversight guideline? and where is oversight coming from?
- creates a protocol --> ensures the rights, safety and welfare of people is maintained
- institutional review board (IRB) / independent ethics committee (IEC)
What is the purpose of Integrity of Conduct and Data relationship of GCP?
guarantee that clinical trials are conducted ethically + resulting data is credible, accurate, and reliable
What is the Goal of GCP Guidelines?
compliance provides public assurance that the rights, safety and well being of trial subjects are protected
The question on the page originate from the summary of the following study material:
- A unique study and practice tool
- Never study anything twice again
- Get the grades you hope for
- 100% sure, 100% understanding
