News

Many of you will be aware that, as a deliverable of the TMF Reference Model initiative, the TMF Survey is designed to provide insights from sponsors, CROs, inspectors, trial sites and other stakeholders, for both paper and electronic TMF management. This is the only non-commercial TMF survey conducted by and for the TMF stakeholder community. […]

The adoption of v3.0 of the TMF Reference Model across industry has been phenomenal. Data suggests that the Reference Model is being used by the majority of commercial clinical trial sponsors and contract research organisations. But we know that the Model is not perfect and it is only when you start to implement it within

An inspection has been announced and you want to prepare the TMF for the inspection. What do you need to think of and what activities are typically conducted to prepare for the inspection? These and many other questions have been addressed through the work that has been performed by the ‘Inspection Readiness’ TMF Reference Model

The TMF Reference Model was last updated in June 2015 so you may be thinking that all has gone quiet and nothing is happening. You couldn’t be farther from the truth! We currently have TWELVE sub-groups working on various initiatives concerning TMF management, involving around 90 members of the TMF Reference Model project team. These

Following the recent Steering Committee elections, we are pleased to announce the new committee, effective 31 March 2016: Elected/Re-elected: Karen Roy – Phlexglobal Eldin Rammell – Consultant Martin Thorley – Pfizer Allison Varjavandi – Astellas Continuing members: Jamie Toth – Daiichi Sankyo Claire Mooney – Quintiles Fran Ross – Consultant Lisa Mulcahy – Consultant Karin Schneider

Based on responses from members of the TMF Reference Model project team, this question has now been included in our Frequently Asked Questions page. A summary is also provided below: Question: Should draft documents be filed in the Trial Master File? Answer: Unanimous opinion across the TMF Reference Model is that draft versions of documents should

Following the expiry of the initial term of office for some TMF Reference Model Steering Committee members, an election was recently held of all members registered with us (541 members). We are pleased to announce the Steering Committee members: Positions only due for revote in January 2016: Karen Roy – Phlexglobal – Chair Steve Scribner

We are pleased to announce that the results from the annual TMF Survey have been analysed and the summary report can be downloaded for free HERE. Some of the highlights that you can find in the report: Only 8% of respondents report NOT having an SOP for TMF Management. Although most TMF seem to contain

Building on the most widely leveraged standardized reference in TMF management today – with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors – version 3.0 of the TMF Reference Model (released at the DIA Annual Meeting in Washington, DC on June 16th) incorporates feedback from this extensive industry

Make sure your perspective is heard, and get valuable insights and data for your Trial Master File (TMF) improvement initiatives. An outgrowth of the volunteer TMF Reference Model initiative, the 2015 TMF Survey is designed to provide year-over-year insights from sponsors, CROs, inspectors, and trial sites, for both paper and electronic TMF management. This is