Set of European guidance documents for clinical trials

Guidance documents for clinical trials are available on the website of the European Commission.

In order to make a distinction between the current applicable documents relevant to clinical trials (authorised under Directive 2001/20/EC) and documents authorised under European Clinical Trial Regulation Regulation 536/2014 (CTR; expected in 2019), these documents are listed in two separate pages.

A number of guidance documents are being revised and updated to bring them in line with the changes required by the CTR. Additionally, new documents were prepared to cover new aspects introduced by the CTR.