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SCOPE Summit for Clinical Ops Executives

Talk Data track

Help Is Here: Interpreting the New ICH E6 R3 Data Governance Requirements

Tue, Feb 4, 2025 · 11:55 AM–12:20 PM EST Rosen Shingle Creek

About this session

The upcoming ICH E6 R3 (GCP) guideline introduces a brand new section related to data governance in clinical trials. Given the critical nature of data in clinical research, proper governance is essential to maintain the reliability of the trial results, protect the participants’ rights and safety, and ensure compliance with regulatory requirements. ACRO and TransCelerate collaborated to deliver a data governance framework and diverse solutions to support the understanding and interpretation of these new requirements.

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