How many times have you heard someone say, “I need to archive this in the TMF” or worse, ask “Do I need to put this in the TMF”? TMF filing is perceived as an extra step “after” the real work of creating and using the document has been done – if the document even “needs” to be in the TMF in the first place.
Changing the conversation from TMF management to document management addresses these issues by taking us from the end of the process - "archiving", which no one wants to do - to the start of the process - generating documents and data, which everyone knows is part of their responsibilities, and which no one saves for later, when they “have some time”.
Companies should have a strategy that encompasses clinical document and data management from the beginning until the end, with the designation of one system for the creation, review, approval, and TMF management of all clinical documents. This removes the need for users to identify “TMF” documents and file them in a special system. If we catch all the documents at the beginning of the document lifecycle in one system, improved TMF completeness inevitably follows. The presentation will discuss advantages and difficulties for contributors and TMF strategy generally based on the presenter's experience.