ACDM News Item

ACDM DMEG shares update on CDISC Community Review

Date: November 2, 2026

Thank you to the ACDM Regulatory Considerations DMEG for sharing the following important update for data managers:

CDISC has released the draft TMF Standard Model v1. While this is not a regulatory publication, it does represent an industry standard and will likely impact TMF operations for data managers. CDISC is asking for industry feedback and will accept comments until November 20th.

According to the CDISC website, the TMF Standard Model v1 is not just a revision of the TMF Reference Model 3.3.1. Instead, the new model “represents a fundamental shift” with a focus on providing evidence, not just artifacts. These changes are meant to bring the new model into alignment with ICH E6 R3.

Data Managers will want to review changes to the Central Study Documents, Data Management and Service Provider Zones, as well as the new eClinical Zone which will now be used to hold records on implementation, testing, operations and oversight of all electronic clinical systems.

A few examples of proposed changes include moving User Access Management, Audit Trial Review, Database Schema and Study Specific Configuration Specifications records to the new eClinical Zone. Other systems-related documents such as the Annotated CRF and Clinical Database Migration records would remain in the Data Management Zone.

Visit the CDISC TMF Standard Model V1 Draft Community Review webpage to learn more about the changes, download the draft model and access the Feedback Form: https://www.cdisc.org/public-review/cdisc-tmf-standard-model-v1-community-review

Explore More News

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 . . .

Recommendation paper on decentralised elements in clinical trials

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

Welcome George Clinical as a new corporate member

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

Welcome Clinion as a new corporate member

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

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 . . .