Role of regulatory authority in biomedical research-2

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Role of regulatory authority in biomedical research-2

We will again briefly cover the ethical guidelines and the intention of these.

International Conference on Harmonization’s (ICH) Good Clinical Practice (GCP) is “an international ethical and scientific quality standard for

ü designing,

ü conducting,

ü recording

ü and reporting clinical trials involving human subjects.

The GCP standard evolved over time is recognized by regulatory agencies around the world. Compliance with GCP provides assurance that data and reported results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial subjects are protected.

Kunda