10 Short Years Ago, The TMF Reference Model Was Born

By Karen Roy

Almost exactly 10 years ago – on the 23^rd of March, 2009 to be precise – a pretty diverse group of about 20 TMF practitioners, regulatory professionals, clinical trial managers, document managers, quality assurance (QA) people, and others involved in clinical research got together on a global phone call. The objective of the call? To begin developing the framework for what would become the Drug Information Association (DIA) Trial Master File Reference Model.

What sparked that first meeting is an interesting story. Lisa Mulcahy and I had been asked to incorporate a TMF structure into the DIA Electronic Document Management (EDM) Reference Model. The EDM group covered the regulatory area, and were looking to standardize document naming and content around electronic common technical document (eCTD) specifications for the clinical trial dossier. Their assumption was that this would be a relatively minor and straightforward task.

Lisa and I got together and quickly realized that it was actually a much bigger job than the EDM group had thought – and it grew from there. Everywhere we went, we talked about the need for standardization around the TMF, and worked to recruit people to the group.

And in fact recruiting people was perhaps the easiest part. We had 20 people from multiple areas and from all over the world in that first meeting and all of us recognized that this was a critical problem that needed to be solved.

The reason is that back then, every single company had its own TMF structure. Nothing was aligned. Organizations had different names for the artifacts and documents, they had documents in completely different orders, and each company had a unique mix of what was included in the Trial Master File and what wasn’t. Some TMFs were limited to clinical operational documents and nothing else. And others covered the whole span of the Trial Master File.