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

Phastar announced as Premier & Conference Dinner Sponsor of ACDM22

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

New online training course – Risk Based Monitoring

The Association for Clinical Data Management is delighted to announce the launch of their . . .

Building data management success in Sponsor/CRO relationships online webinar 30th April

The ACDM is partnering with PCMG to offer a webinar on Building data management success in . . .

ACDM21 – Location Announced

We are delighted to announce that ACDM21 will take place from the 7th-9th March at the . . .

ACDM Hot Topic Discussion – Implications of COVID-19 on clinical data management activities globally

Friday 3rd April from 12:00 – 13:00 UK Time ACDM members and non-members are invited to . . .

ACDM eDigital DMEG publishes its GDPR Q&A report

ACDM’s eDigital team are currently discussing elements of GDPR, Wearables and EHR . . .

ICON to be Premier & Award Sponsors for ACDM20

The Association for Clinical Data Management are delighted to announce that ICON will be . . .

New Online Learning Course – Understanding Laboratory Data

The Association for Clinical Data Management is delighted to launch their 4th online . . .

Nominations now open for ACDM Awards 2020

The Association for Clinical Data Management are delighted to announce the opening of . . .

Phastar announced as Networking Sponsor for ACDM20

The ACDM are delighted to announce that Phastar are to be Networking & Conference . . .

ACDM20 Dates & Venue

The ACDM are delighted to announce that ACDM20, the 2020 ACDM Annual Conference will take . . .

Launch of Online Training from ACDM

The Association for Clinical Data Management is delighted to announce the launch of Online . . .