Website Migration

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!

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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

REGISTER NOW

 

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