Please note that over the weekend of 6/7 April, the TMF Reference Model website will be migrated to a new hosting provider. During this time, the content may not be accessible. We will try to keep disruption to a minimum.
The new service will be advertisement free. In addition, over the next few weeks we shall be migrating some of the features that are currently managed on separate platforms (e.g. our Yahoo! Groups discussion forum) into our website.
Come back soon!
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 has been revised. The document has been updated as follows.
“Slides were based on the draft of the TMF guidance at that time. The Q&A question 27 answer is compatible and clarifies why remote access to such information would not be acceptable. The guidance since then has been subject to some revisions. For remote access, the following is now stated:
‘Remote access by sponsor or CRO personnel to the investigator TMF should only be possible to the documents where personal data that enable the data subjects to be directly identified (i.e. direct identifiers of trial subjects) is not present or has been pseudonymised’.”
The full Q&A document is available to download from our Resources page.
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, kindly hosted by Wingspan Technology (an IQVIA company). Learn about the key success factors facing life sciences professionals in embracing the emerging TMF Exchange Mechanism Standard.
Register directly by clicking HERE.
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 TMF Reference Model and the eTMF Exchange Mechanism Standard. The TMF vendor community involved in the eTMF Exchange Mechanism Standard will also be present and have kindly agreed to contribute towards drinks and snacks!
The meeting will be at 5.30 pm until 7.00 pm on Tuesday June 26 in the Otis Room at the Westin Boston Waterfront Hotel. This meting is not restricted to conference attendees; anyone with an interest in the Exchange Mechanism Standard is welcome to attend.
So that we have an idea of likely attendance, please let us know using the form below if you are interested in attending this launch event.
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.
To provide feedback please use the form that you can access at the following link: https://goo.gl/forms/fX2xmD1ACOJSCiVy2. This link is also published on our Resources page.
Trial Master File Reference Model 