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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Welcome Zilla Clinicals as a new corporate member

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

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Challenge ChatGPT: CDMs vs AI

Following a recent Hot Topic discussion that explained how machine learning models are . . .

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Welcome Boehringer Ingelheim as a new corporate member

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

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Welcome Datacapt as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Datacapt as a . . .

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