GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected [1]. It was finalised in 1996 and became effective in 1997, but was not enforced by law at that time.

Why was the ICH GCP established?

So Why ICH-GCP

The two have been developed together to ensure that various countries are working to the same standards within the same timescales to protect all research participants. ICH, you could argue, was the more legal wordy element of the two, whereas GCP is more focused on the patient side of the study.

What is the difference between ICH and GCP?

ICH-GCP states that the monitor should be the one to verify the legibility of documents, while Indian GCP states that the monitor also needs to inform the Sponsor and Ethics Committee for any violations from the protocol.