by Sarah Hitching
A long time ago, in 2007, a small group of TMFers, led by current HSRAA member Eldin Rammell and including Sarah Hitching, also a current 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.
But what does this have to do with the HSRAA or the current TMF Reference Model?
There is a link, albeit a long link, between the GCP-RMA and the HSRAA. 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.
But still, what is the link to the HSRAA? In 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 led this group to brainstorm and decide on the new name.
So that explains the link from GCP-RMA to the HSRAA, but what about the link between the GCP-RMA Fileplan and the TMF Reference Model?
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 presented the GCP-RMAs 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.
From GCP-RMA to SAG to HSRAA and from GCP-RMA Fileplan to TMF Reference Model, your organisation has been influencing and changing the way the industry handles TMFs, improving processes, empowering change management, and leading the way forward.
Thank you to Sarah for this fantastic article – we hope you enjoyed reading it.
Sarah Hitching, Hedian Records Management