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