Following the receipt of clarification from the MHRA on access to the investigator TMF, the Q&A document that was generated following the European TM Summit
Category: News
FREE Webinar: Embracing the TMF Exchange Mechanism Standard
Final reminder that our next free Exchange Mechanism Standard (EMS) webinar is on Thursday December 13 at 7am PT, 10am ET, 3pm UTC, 4pm CET,
eTMF Exchange Mechanism Standard Launch Meeting Announced
We are delighted to announce the launch of version 1 of the eTMF Exchange Mechanism Standard to support eTMF transfer during the DIA Annual Meeting
TMF Plan Template Now Available
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
Update: Minor Revision to Milestones Worksheet
It was recently noted by one of our very observant users that the Milestones worksheet included eight artifacts for which milestones were not suggested! Once
When Are We Permitted to Destroy Original Paper Documents?
The DIA Document & Records Management Community completed an initiative in 2012 to define a Framework for the Destruction of Paper. The results have been
eTMF Exchange Mechanism Standard Moves Ever Closer
The eTMF Exchange Mechanism Team – a sub-group of the TMF Reference Model project – has been working on a standard1 for the transfer of
Medical Devices Sub-team Started
The TMF Reference Model has been developed to be equally applicable to clinical trials using investigational medicinal product (IMP) and those using medical devices and
Milestones / Events Published for TMF Reference Model Artifacts
We are pleased to announce the publication of the final deliverables from the Milestones Sub-group, led by Kathleen Kirby. The purpose of this document is
Project Charter Updated
It has been over eight years since the charter for the TMF Reference Model was published (April 2009). A lot has changed in those eight