TMF As A Part Of The Bigger Records Management Picture

By Eldin Rammel

It is interesting – at least to some of us! – that the management of trial master file content has developed into such a niche area of expertise, with plenty of regulations, requirements, systems and processes that are almost unique to this specific area of activity. That is why we place so much effort in monitoring the regulatory landscape and in maintaining dialog with our industry colleagues to ensure we stay at the forefront of this exciting subject. TMF management requires a thorough understanding of the clinical trial process, the pertinent regulations and legislation, and the purpose and value of each document in relation to trial activities.

However, it is also very important to remember that TMF management is just one part of a much larger network of systems and processes. At its most fundamental level, the implementation of optimal systems and processes for TMF management requires a thorough understanding of Good Records Management Practices….. gRMPs. We need to understand how trial documents are being managed in the context of their overall document lifecycle, from creation through to their final disposition. TMF management is about more than efficient filing of documents; it touches on document and template design; taxonomies and classification schemes; information governance; and data preservation…. to name just a few records management issues we need to be aware of.