Good Clinical Practice (GCP) Practice Exam

How does Good Clinical Practice relate to the Declaration of Helsinki?

1. GCP is derived solely from the Declaration of Helsinki

2. Both emphasize the importance of trial subject rights and safety

3. GCP does not reference the Declaration of Helsinki

4. GCP is less stringent than the Declaration of Helsinki

The correct answer is: Both emphasize the importance of trial subject rights and safety

The relationship between Good Clinical Practice (GCP) and the Declaration of Helsinki is fundamentally based on the shared commitment to the rights, safety, and well-being of trial subjects. Both frameworks are centered around ethical principles that guide researchers in conducting clinical trials responsibly. GCP provides a broader regulatory framework that not only incorporates ethical considerations but also includes guidelines for the design, conduct, recording, and reporting of clinical trials that involve human subjects. The Declaration of Helsinki, developed by the World Medical Association, outlines ethical principles for medical research involving human subjects, emphasizing the need for informed consent, respect for participants, and the importance of a favorable risk-benefit ratio. By focusing on the protection of subjects' rights and safety, both GCP and the Declaration of Helsinki ensure that ethical standards are upheld in clinical research, underscoring the importance of participant welfare in the pursuit of scientific knowledge. Thus, the emphasis on trial subject rights and safety is a cornerstone that connects GCP with the principles laid out in the Declaration of Helsinki.