News

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 in Boston, USA. To mark this occasion, DIA have kindly provided facilities during the DIA Annual Meeting in Boston. Paul Fenton, Elvin Thalund and Karen Roy will be presenting the […]

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

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 we were made aware of this gap, the milestones team very rapidly reviewed these eight artifacts and assigned milestones. The revised worksheet (v1.1) has now been approved by the Steering

The DIA Document & Records Management Community completed an initiative in 2012 to define a Framework for the Destruction of Paper. The results have been widely published and used by many companies to define policies and SOPs for document retention, retrieval and destruction. Many colleagues on the TMF Reference Model project participated in this initiative.

The eTMF Exchange Mechanism Team – a sub-group of the TMF Reference Model project – has been working on a standard1 for the transfer of TMF data between different eTMF systems for around three years. The objective is to define a simple standard that could be used in a number of scenarios: Final export of

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 diagnostics (MD&D). The model includes metadata to designate certain artifacts as corresponding to IMP trials or to device trials. However, in practice, it is sometimes difficult to apply the model

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 to define the latest point in time when an artifact is to be submitted / filed within the TMF. Of course, there is a regulatory expectation that artifacts are filed

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 years but the charter has remained the same. So the Steering Committee felt it was high time for a review! The Steering Committee are pleased to announce the publication of

Successful management of a TMF, whether in paper or electronic form, is highly dependent on the classification system (e.g. TMF Reference Model) and the ability for a reviewer to identify and locate documents by specific attributes, such as the document date. However, deciding which date to use as the “document date” can often be subjective and

What is Quality Control and what does it look like for your clinical trial? Those are some of the questions you may have about TMF Quality that are addressed by The Trial Master File Reference Model Quality Group’s (TMF RM QG) latest output documents. They have recently released their expert recommendations for a thorough and