Evolving Trial Master Files Require Experienced TMF Resourcing

Dawn Niccum, inSeption Group

Inexperienced individuals often struggle to maintain an up-to-date and inspection-ready TMF, producing instead a TMF that falls short in terms of quality, completeness, or timeliness. Experienced TMF resources bring is a keen understanding of clinical trial documents — what they are, where they go, and when to ask questions.

While many documents are generated through activities conducted by the clinical team, the TMF should contain documents from all functions, including data management, regulatory, and clinical supply. TMF team members need to work cross-functionally (a skill developed through experience) to ensure documents from all team members are filed in a timely manner.

Moreover, in the digital age, records formerly archived in a file room that were not easily retrievable now exist as a dynamic structure that is always available. Technology not only has removed the veil from the TMF, it also has introduced discussion of how this tool (the TMF) can best serve study teams in maintaining control of their trial — or, more to the point, proving to regulators that control of the trial has been maintained throughout.