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ICH E8(R1) General Considerations for Clinical Studies
On 28 April 2022 the ICH announced that Step 4 - Introductory Training Presentation – is available on the ICH website.
This document has been signed off as Step 4 document (6 October 2021) to be implemented by the ICH Regulatory Members. This document was developed based on a Concept Paper (14 November 2017) and Business Plan (14 November 2017).