Early History of the CDISC TMF Reference Model:

2007 to date – Creation of the Trial Master File (TMF) Reference Model
A long time ago, in 2007, a small group of TMFers, led by current HSRAA member Eldin Rammell and including Sarah Hitching, founder of Hedian Records Management and also a current HSRAA member, met in Weesp in the Netherlands to discuss a standard fileplan. 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 TMF index 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.

The GCP-RMA no longer exists, but it was active from 2001, when it was formed out of the Records Management Working Party of the European Forum for Good Clinical Practice (EFGCP), to 2016 as an industry group for Records Managers working in the GCP space. The Scientific Archivist Group (SAG) was also in existence with many members in common, and so it was decided to close GCP-RMA and hand over to SAG. The GCP-RMA Close Out Meeting was held on 3rd to 4th March 2016 in Nottingham, UK, and both Eldin and Sarah were present. This meeting was documented on LinkedIn for prosperity.

Around 2018, SAG rebranded to the Health Sciences Records and Archives Association (HSRAA) as a way of representing all of its members and their roles more fully. At the time, both Eldin and Sarah were on the SAG Operational Committee, and Eldin Rammell led this group to brainstorm and decide on the new name.

Around 2008, the GCP-RMA working group recognised that not only would it be difficult to get adoption of the emerging Fileplan across industry from such a small group, but also that there were many synergies with the Drug Information Association (DIA) Document Management Special Interest Group. Eldin Rammell agreed with the Chair, Lisa Mulcahy, that the GCP-RMA Fileplan would be a useful starting point for a Reference Model to complement the already existing Common Technical Document (CTD) Reference Model. Eldin Rammell presented the GCP-RMA Fileplan at the DIA Document Management conference in Vienna, Austria (December 2009).  Subsequently, the first version of the TMF Reference Model was released in June 2010. This was as a result of the formation in 2009 of the TMF Reference Model team, a part of the Document and Records Management Community of the DIA. Sarah Hitching was part of that team, providing feedback on section 11, Statistics of the TMF Model version 1.

Since June 2022, the TMF Reference Model became part of CDISC which creates connected standards throughout the trial information lifecycle.

From GCP-RMA Fileplan to the DIA TMF Reference Model and now CDISC TMF Reference Model, seasoned TMFers have come together as volunteers to create the industries only standardised TMF index for all to use, influencing and changing the way the industry handles TMFs, improving processes, empowering change management, and leading the way forward.

You can also read the article on the HSRAA website.