ICH E6(R3) Guideline reaches Step 4 of the ICH Process
Date: January 28, 2025
ICH E6(R3) reaches Step 4 of the ICH Process on 6th January 2025.
The guideline establishes a unified standard to support the mutual recognition of clinical trial data by regulatory authorities in ICH member countries and regions. It builds upon the key concepts presented in ICH E8(R1) General Considerations for Clinical Studies. The guideline consists of principles and annexes, which provide further elaboration on these principles, including specific details for various types of clinical trials.”
ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
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