AI model trained on de-identified data from 57 million people

Researchers at UCL have trained an AI model using de-identified data from 57 million . . .

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ACDM Regulatory Considerations DMEG Update: ICH E6 (R3) GCP Final Publication Released

The final publication of ICH E6 (R3) Good Clinical Practice (GCP) General Principles and . . .

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ICH E6(R3) Guideline reaches Step 4 of the ICH Process

ICH E6(R3) reaches Step 4 of the ICH Process on 6th January 2025. The guideline . . .

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U.S. Food & Drug Administration: Draft Guidance for Industry and Other Interested Parties

The U.S. Food and Drug Administration has issued its first guidance on the use of . . .

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ACDM DMEG News: Regulatory Updates and Forthcoming Challenges for 2025

As 2024 draws to a close, the Regulatory Considerations Data Management Expert Group . . .

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Audit Trail Review DMEG Update – New Guide

The Audit Trail Review (ATR) DMEG has been hard at work putting the finishing touches on a . . .

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Risk Based Quality Management DMEG Update – Recent Discussions

This year our focus has switched away from generalised RBQM to applying risk-based . . .

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Regulatory Considerations DMEG Update – September 2024

The Regulatory Considerations DMEG are waiting for the release of ICH GCP E6 (R3) Annex 1 . . .

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Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO)

This article has been submitted by Leeni Joshua of ICON plc Introduction: Digital Data . . .

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Guidance for Industry: Conducting Clinical Trials With Decentralized Elements

The Conducting Clinical Trials With Decentralized Elements final guidance has now been . . .

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Welcome FGK Clinical Research as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome FGK Clinical . . .

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Welcome LINK Medical as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome LINK Medical as . . .

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