The TMF Plan Template Subgroup of the TMF Reference Model Project is pleased to announce that the TMF Plan Template version 1.0 is now available for use. You can download this free of charge from our Resources web page.
The purpose of a TMF Plan is to leverage TMF expectations between sponsors and relevant TMF stakeholders (e.g., CROs/vendors) to ensure delivery of a high quality TMF, and that what is expected from all concerned parties (CROs, vendors and sponsors) is clearly defined. The complexity of the TMF is an all too familiar reality in clinical trial conduct. The delegation of varied responsibilities to CROs/vendors, each with their unique internal procedures, necessitates careful planning for managing TMFs. What is the structure of the TMF and where will it be located? What is the procedure for filing essential documents and how will access to the TMF be granted to those who need it? These are just some of the questions that we hope can be answered by adopting the TMF Plan template. Rather than attempting to create your TMF Plan from a blank page, the TMF Reference Model Project are making available this template that you can use as your starting point.
It is important to note that this TMF Plan Template has been written to cover both sponsor and investigator TMFs but is easy to adapt if your organization has separate, documented procedures for each type of document.
The template includes green text which is there to provide guidance to the user on how to best adapt the TMF Plan depending on the type, size, complexity of the clinical trial. As such, it should be taken as a recommendation on how the template can be used, rather than how it should be used. Users of the template are highly encouraged to adapt the document to complement their needs and to cross-reference internal SOPs or other written procedures rather than duplicating the text within this plan.
Whereas many questions have been considered, and hopefully addressed, we are well aware that this first version of the template may not be perfect and can be improved based on your feedback as you begin using it. This is the start of a conversation and we really want to hear your feedback as you begin using it.