The eTMF Exchange Mechanism Standard (eTMF-EMS) provides a solution for exchanging TMF content with high quality and minimal effort across sponsors, CROs, sites, vendors and integrators. The TMF Reference Model Exchange Mechanism team has created a survey to understand industry perspectives on eTMF-EMS with the goal of increasing its adoption. The team will present a summary of findings at the TMF Reference Model general meeting in early 2021.
The team invites anyone who is involved in managing a clinical trial master file or is a stakeholder of TMF operations to take the survey at https://montrium.typeform.com/to/xsm692NG.
Release 19.3.2 of the eTMF Exchange Mechanism Standard (eTMF-EMS) has been published, effective October 25. This is a minor release related to changes and updates to the specification for the eTMF-EMS.
You may access the Release Notes, as well as the specification for the eTMF-EMS, version 1.0.1 on the Resources web 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.
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
Following review by the TMF Reference Model Steering Committee, the Charter of the Exchange Mechanism Standard (EMS) subgroup has been finalized and published. The Charter can be downloaded here.
Following a consultation period in which industry representatives were provided with an opportunity to review the draft TMF Exchange Mechanism Standard, their feedback is now being reviewed by the Exchange Mechanism business and vendor teams. Feedback has been provided by a wide range of stakeholders, including trial sponsors, CROs, consultants, eTMF vendors and other service and system providers.
Completion of the feedback review is expected around March/April, following which the revised standard will go through a road-test. Any willing vendor or business users who would like to participate in the road-test should contact the exchange team.