ICH E8(R1): General Considerations for Clinical Studies

Name: ICH E8(R1): General Considerations for Clinical Studies
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.