Creation of the Trial Master File (TMF) Reference Model
Where it Began:
In 2007, a small group of TMFers, led by Eldin Rammell and including Sarah Hitching, met in Weesp in the Netherlands. It was the 26th September and the start of a 2 day meeting in which the Good Clinical Practice – Records Managers Association (GCP-RMA) would put together the first ever standard file plan. This plan was based on the processes of a clinical trial. The original agenda for that meeting and the GCP-RMA fileplan still exist and can be found here.
GCP-RMA Becomes the HSRAA:
The GCP-RMA no longer exists, but it was active from 2001 to 2016 as an industry group for Records Managers working in the Good Clinical Practice (GCP) space. In March 2016, the GCP-RMA amalgamated with the Scientific Archivist Group (SAG) which in 2018 rebranded to become the Health Sciences Records and Archives Association (HSRAA).
TMF Reference Model Team:
Around 2008, the small GCP-RMA working group recognized that it would it be difficult to get the emerging Fileplan adopted across industry. At the same time, the group recognized that there were many synergies with the Drug Information Association (DIA) Document and Records Management Community. In 2009, a sub team, the TMF Reference Model team, was created and work on the first TMF Reference Model began.
The GCP-RMA Fileplan and TMF Reference Model
Eldin Rammell subsequently presented the GCP-RMA Fileplan at the DIA Document Management conference in Vienna, Austria (December 2009). This fileplan, along with other indexes, was used as a resource to help produce the first version of the TMF Reference Model on 10th June 2010. The GCP-RMA Fileplan was in particular used in the production of TMF Reference Model V2.0 in June 2012. At this time, process based metadata was incorporated.
CDISC and the TMF Reference Model:
Since June 2022, the TMF Reference Model became part of CDISC. CDISC creates connected standards throughout the trial information lifecycle. CDISC are now working towards creating a TMF Standard Model which is due for release in 2027.
The CDISC TMF Reference Model, as it exists today, is the result of seasoned TMFers working together as volunteers to create the industries only standardized TMF index for all to use. The CDISC TMF Reference Model has influenced and changed the way the clinical trial industry handles TMFs. It has improved processes, empowered change management, and led the way forward.