MHRA Q&A Document Revised

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.


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, 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.

Webinar Reminder: October 11, 2018

Register today for the FREE webinar: TMF Reference Model: eTMF Exchange Mechanism Standard (eTMF-EMS) – A Technical Perspective
DATE: October 11 @ 10:00am EDT

In our upcoming webinar, we will cover technical perspectives of the  Exchange Mechanism Standard. We will start by going over a recap of the standard and how it can help your current systems and processes.

This webinar will cover:

  • What is the TMF EMS?
  • How does the standard work and how it could be used?
  • How can sponsors, CROs and vendors implement the standard in their eTMF?
  • Insights into the practicalities of implementing the standard technically



Bridging Regulatory Quality and Operational Efficiency with Open Standards

Save your seat for the upcoming webinar!
Accelerating clinical trials with open standards
Central to the elimination of bottlenecks and unnecessary rework in the clinical trial continuum is automation and integration between eClinical applications based on open standards.
Existing systems (CTMS, eTMF, etc.) only support clinical trial functions in silos. The challenges in integration of eClinical systems stems from the lack of standards, it’s simply not enough to have APIs available.
Standards provide stakeholders with a basis for mutual understanding and are critical tools to facilitate communications. Open standards help fuel compatibility, interoperability, simplify trial executions and speed time-to-market.
The new eTMF Exchange Mechanism provides the cornerstone in collaboration between all study startup and executive stakeholders, including sponsors, CROs, investigative sites and regulatory and ethical committees.
Date/Time:  August 28, 2018 @ 3:00 pm BST, 10 am ET, 7 am PT

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 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.

Is the TMF Reference Model applicable to the investigator site file / regulatory binder?

The TMF Reference Model is intended to cover the full scope of the Trial Master File as described in ICH E6 Good Clinical Practice Guidelines. ICH E6 GCP Guidelines include all the content that the sponsor is required to maintain in the sponsor TMF and all the content that the investigator is required to maintain in the investigator TMF; the latter is sometimes referred to as the ‘investigator site file’, the ‘ISF’, or the ‘regulatory binder’.

The structure of the TMF Reference Model spreadsheet includes two columns where artifacts are designated as being sponsor artifacts or investigator artifacts. These two columns are shown for non-device trials (columns N and O) and for device trials (columns P and Q). Any suggestion that the Reference Model does not include investigator site documents is incorrect.

The TMF Reference Model project team have received several comments over the years that suggest the Model can be difficult to apply to the investigator TMF and that it is not consistent with file structures that are typically used. The Steering Committee recently (January 2018) agreed to be involved with an industry initiative being organized by MAGI to introduce improvements. Representatives from the TMF Reference Model project team will participate in the MAGI project to produce an investigator TMF Reference Model that will be available as a standalone product from MAGI. Once this work is complete, it will be fully integrated into an update of the TMF Reference Model; we want to continue making available a single consistent Model across the sponsor and investigator TMFs. The objectives of this initiative are:

  • to identify any missing artifacts relevant to the investigator TMF;
  • to identify sub-artifacts that are relevant to the investigator TMF e.g. examples of source data that might be found in the investigator TMF;
  • to review the structure of the content to ensure alignment with regulatory expectations and industry best practice;
  • to ensure the content reflects requirements and best practice globally.