ACDM News Item

Audit Trail Review DMEG Update – New Guide

Date: October 16, 2024

The Audit Trail Review (ATR) DMEG has been hard at work putting the finishing touches on a paper around ATR, titled Getting started with Audit Trail Review in Clinical Trial data: An Essential Guide.

This guide draws on our combined understanding and knowledge of this complex process. The goal of the paper is to demystify the implementation of an ATR process for clinical trial data, outlining the essential aspects, with suggestions and recommendations for how organisations can get started with this process. We share examples of findings and operational insights into the process, discuss CRO and Vendor perspectives, and conclude with thoughts on future directions in the ATR space.

We are pleased to share that the paper can now be read on our ATR DMEG page. Click here to find out more about our work and view the paper.

– Jennifer Nielsen, ATR DMEG Chair

Explore More News

HMA/EMA joint Big Data Steering Group: Big Data Workplan 2023-2025

The joint HMA-EMA Big Data Steering Group (BDSG) have released their latest workplan, . . .

ACT EU PA04 – Multi-stakeholder Workshop on ICH E6 R3

As part of the Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan . . .

European Medicine’s Agency – Reflection paper on the use of artificial intelligence in the lifecycle of medicines

The EMA has opened a public consultation on a reflection paper presenting views . . .

Welcome Instem as a new corporate member

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

Regulatory Considerations Expert Group reviews draft FDA Guidance

The ACDM Regulatory Considerations Expert Group have reviewed and submitted comments on . . .

ICH GCP E6 Revision 3 is here. Regulatory Considerations Expert Group to review

The R&D industry, especially those that are working on clinical trials, have been . . .

Welcome Algorics as a new corporate member

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

Consultation response on legislative proposals for clinical trials

The MHRA have published the public consultation response to the proposals to reform the . . .

New MHRA Guidance

The MHRA have published new guidance on ‘Software and Artificial Intelligence (AI) as a . . .

FDA Guidance for Industry

The FDA has issued a final guidance to provide information on risk-based approaches to . . .

Guideline on computerised systems and electronic data in clinical trials

The European Medicines Agency (EMA) have published the new guidelines on computerised . . .

Welcome IROS – Insights Research Organization & Solutions as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome IROS – Insights . . .