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In the past six years at Paragon, I’ve had the privilege of supporting eTMF engagements across a wide variety of life science organizations using many different eTMF solutions. As vendor-neutral consultants with dozens of TMF engagements to date, you might think we’ve heard it all.


But it’s so not true! Every engagement has new variables, new challenges, new considerations, and always opportunities. That’s why I am delighted to participate in the MHRA’s upcoming TMF Focus Day, in Leeds UK on September 5, 2017 (https://mhragcp-tmfworkshop.co.uk/home). This is an unprecedented opportunity to directly discuss with a TMF-forthcoming Health Authority all the burning questions on inspecting GCP Essential Documents.

The MHRA recently published the 2015-16 GCP Inspection Metrics, where essential documents/record keeping continues to be a significant source of critical and major findings (Good clinical practice inspection metrics for 2015 to 2016). Year over year, the TMF issues in GCP inspection remains such a significant problem that they are convening this forum to support moving the bar on the industry’s TMF compliance results. 

The MHRA TMF Focus Day features case studies, panels and discussions including:

  • MHRA: Inspect Part of a TMF / TMF Surgeries
  • MHRA: Assessing Compliance from Documents, Data and eSystems
  • MHRA: The Inspector’s User Requirements for TMF
  • Industry: What’s (Been) Wrong with TMFs – Is it the same for everyone?
  • Industry: Fixing the Problem Within the Organization
  • Industry: Fixing the Problem - Challenges When Multiple Organizations Involved
  • MHRA: Challenge of eTMFs and way forward? What more can MHRA do? Why are there still critical findings for eTMFs?

I'm personally interested in perspective and discourse on these topics:

  1. Certified copies: Does guidance suggesting that certification is accomplished with a signature restrict the move to paperless trials?
  2. Named archivist: How extensive is the gap in sponsor control of all TMFs for every trial run by that sponsor?
  3. eTMF/eISF: Could a monitor’s cell phone picture of a site’s original document uploaded by the monitor into an eTMF pass inspection?

What burning question do you have for the MHRA? I expect to see many TMF industry colleagues at the meeting, and many more are not able to attend. The MHRA is very interested in receiving as many questions as possible in advance of the TMF Focus Day. Registered delegates can ask questions directly, and industry questions are being collected at [email protected]

In addition, we are hosting a survey (https://www.surveymonkey.com/r/Z2TPLKL) to assess your perspective across the spectrum of TMF process, people, tools, and governance, and give you an opportunity to anonymously ask the MHRA anything. We will anonymize responses and generalize results. In advance of the session, we will also be releasing some materials we have crafted over the years about TMF inspection, eTMF optimization, and GCP compliance. Click here to receive an advanced copy of the materials.