Skip to content

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

ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management

The ACDM Regulatory Considerations have reviewed the Revision 1 to the ICH E8 Guidelines . . .

Read More

ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”

https://acdmglobal.org/wp-content/uploads/2022/04/ACDM_FDA_DHT.pdf

Read More

Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials

Dear Colleague, We have just launched our 8-week public consultation on proposals for . . .

Read More

Signant Health are ACDM22 Photography sponsors

The Association for Clinical Data Management are delighted to announce that Signant Health . . .

Read More

Anju Software is exhibiting at ACDM22

The Association for Clinical Data Management is delighted to announce that Anju Software . . .

Read More

SGS Health Science to sponsor ACDM Awards for the second year running

The Association for Clinical Data Management are delighted to announce that SGS Health . . .

Read More

ACDM Interactive

The ACDM would like to thank everyone involved with ACDM Interactive in Manchester. The . . .

Read More

nuvoteQ to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that nuvoteQ are to . . .

Read More

IQVIA to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that IQVIA are to be . . .

Read More

Anju Software to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that Anju Software . . .

Read More

CORE to be Premier and Interactive Sponsor for ACDM22

The Association for Clinical Data Management is delighted to announce that CORE from the . . .

Read More

eClinical Solutions to be Premier and Communications & Social Media Sponsor for ACDM22

The Association for Clinical Data Management is delighted to announce that eClinical . . .

Read More