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

Clinical Trials for Medicines – New Notification Scheme

The MHRA have recently launched a new notification scheme, the first step in their . . .

EMA Management Board: Highlights of October 2023 meeting

The EMA’s Management Board met on 5 October in Amsterdam. The article below covers the . . .

Welcome Mednet as a new corporate member

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

Welcome Allucent as a new corporate member

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

Welcome KCR as a new corporate member

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

Welcome Debiopharm as a new corporate member

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

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 . . .