Lecture title - Good Clinical Practice (GCP)

4 important questions on Lecture title - Good Clinical Practice (GCP)

What is Good Clinical Practice (GCP)?

An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involved the participation of human subject

What is the overarching law that the GCP adheres to?

the rights, safety, and well-being of subjects are the most important considerations and should always prevail over the interests of science and society

GCP principals can be summarised into 3 relationships. what are these relationships?

  • The Primacy of the Participant
  • The Foundation of Ethics and Science
  • Integrity of Conduct and Data
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What the does Primacy of the Participant relationship say?

the interests of a person will always prevail over the interests of science and researchers must weigh the foreseeable risks against the anticipated benefits before the experiment commences.

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