Trial Master File Reference Model Group Officially Affiliates with CDISC

AUSTIN, Texas–(BUSINESS WIRE)–#cleardataclearimpact–CDISC today announced an expansion of its offerings with the official affiliation of volunteer-based Trial Master File (TMF) Reference Model Group. The combined organizations will operate under the CDISC brand and continue serving the clinical research community by providing resources that foster greater efficiencies across the industry ecosystem.

Like CDISC, the TMF Reference Model Group began as a grass roots initiative in response to an urgent need originating from the clinical research community. As a result, the TMF Reference Model Group developed a taxonomy reference model for a clinical trial master file that any organization can use. A trial master file contains essential documents needed to ensure patient safety, data integrity, and the ability to reconstruct the trial, and that are subject to regulatory agency oversight.

�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. We’ve achieved great success in aligning the industry on the contents and structure of the TMF,” said Karen Roy, TMF Reference Model Steering Committee Chair. “Now we need support and resources to continue to evolve towards more ambitious goals. We believe CDISC is the perfect partner for future-proofing the model.”

This affiliation represents a natural progression of the TMF Reference Model Group’s four strategic goals: to evolve, maintain community engagement, formalize the model with regulatory authorities and expand and increase sharing of expertise. The TMF Reference Model Group will leverage CDISC’s infrastructure and tools to strengthen future development of the TMF Reference Model as part of an overall Community of Excellence.

“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,” said David Evans, President and CEO, CDISC. “This strategic affiliation aligns well with CDISC’s vision of driving clinical research forward.’’

In the coming months the TMF Reference Model Group and CDISC will work together to align processes that support the development, curation, and maintenance of standards that will be freely available via the CDISC website.

ABOUT CDISC

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.

About Trial Master File Reference Model Group

The Trial Master File (TMF) Reference Model Group was formed in 2009 within the Document and Records Management Community of the Drug Information Association (DIA) and released version 1.0 of the TMF Reference Model in 2010. The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. The all-volunteer-run organization comprises over 330 members and is governed by a 14-person steering committee composed of industry experts from across the clinical research spectrum. For more information, please visit https://tmfrefmodel.com/.

Contacts

Ann P. White

+1.512.363.5826

awhite@cdisc.org