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.

Advertisements

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

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.

TMF Plan Template Now Available

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.