The Clinical Data Interchange Standards Consortium (CDISC) has announced the official affiliation of Trial Master File (TMF) Reference Model Group, expanding its offerings.

Set to operate under the CDISC brand, the merged organisations will continue to provide the clinical research community with resources that advance efficiencies across the industry ecosystem.

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The volunteer-based TMF Reference Model Group started as a grass roots initiative to cater to the urgent need of this community.

A taxonomy reference model created by the TMF Reference Model Group for a clinical trial master file can be used by any organisation.

The file comprises documents that are needed to ensure safety of the patient, data integrity, and the ability to reconstruct the trial. They are subject to regulatory agency oversight.

TMF Reference Model Steering Committee chair Karen Roy said: “The TMF Reference Model is the product of a ten-year collaboration by hundreds of volunteer contributors across pharma, biotech, med device, CROs, vendors and consultants.

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“We’ve achieved great success in aligning the industry on the contents and structure of the TMF. Now we need support and resources to continue to evolve towards more ambitious goals.”

Following the affiliation, the TMF Reference Model Group will now leverage the infrastructure and tools of CDISC for strengthening its future development.

CDISC president and CEO David Evans said: “We look forward to bringing a new dimension to CDISC by broadening the depths of our offerings to support clinical trial operations and facilitate operations at research sites.”

The TMF Reference Model Group and CDISC will work in the future for aligning the processes.

These processes support the development, curation, and standards maintenance that will be available through the CDISC website for free.