Clinical Data Management News & Insights

Established in 1987, The Association for Clinical Data Management (ACDM) is a Membership Organisation for individuals and organisations involved in the management of clinical data.

Please find below the latest news from ACDM, our members, the CDM community and the wider industry.

ACDM News

Consultation response on legislative proposals for clinical trials

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

ACDM News

New MHRA Guidance

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

ACDM News

FDA Guidance for Industry

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

ACDM News

Guideline on computerised systems and electronic data in clinical trials

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

ACDM News

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

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

ACDM News

Recommendation paper on decentralised elements in clinical trials

Following their meeting on 4 Oct, the EMA/HTAs and EC have published a recommendation . . .

ACDM News

Welcome George Clinical as a new corporate member

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

ACDM News

Welcome Clinion as a new corporate member

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

ACDM News

Welcome ClinoSol Research as a new corporate member

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

CTU DMEG Update

The CTU DMEG has been actively discussing common problems that data managers face in . . .

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 . . .

ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”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