Transcription of GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1)
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GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1)
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1) Final version Adopted on 6 October 2021 This Guideline 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. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of ICH regions. i E8(R1) Document History E8 Code History Date E8 Approval by the Steering Committee under Step 4 and recommendation for adoption by ICH regulatory bodies. 17 July 1997 Revision of E8 Code History Date E8(R1) Adoption by the Regulatory Members of the ICH Assembly under Step 4. 6 October 2021 Legal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times.
The ICH document "General Considerations for Clinical Studies" is intended to: 1. Describe internationally accepted principles and practices in the design and conduct of clinical studies that will ensure the protection of study participants and facilitate acceptance of data and results by regulatory authorities 2.
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