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Dear colleagues,
Would you please advise on filing the documents related to EU Clinical Trials Regulation 536/2014? There will EU level documents applicable to several EU countries. Also for the EU countries there will be no longer split into EC & Competent Authorities submissions and correspondence. There will be one submission per country and one approval document (which will be a joint decision of EC & RA). Where to place such documents now? Should we locate them in 03. Regulatory?
Thank you a lot and best regards,
Maria Pedko -
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Hello, we have not yet addressed this to be honest. It’s six of one, half a dozen of the other – there’s no right answer, only the one that best suits the kind of TMF system you have, the filing responsibilities in your company, and other factors. In our case (this is a personal opinion again we have not discussed in my company) I might be tempted to file it both Zones 03 and 04, so that our automatic completeness tracking tool is accurate. Yes, it is technically content duplication, but for my part, given the limitations of our eTMF system, content duplication if it serves distinct, separate documentation purposes, is acceptable. I am very open to dissenting opinions!
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The new Clinical Trials Regulation (EU) 536/2014 has raised questions about possible new document types for the TMF and how they might be filed and managed.
https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
In response to those questions, the TMF Reference Model Steering Group will be holding an all-hands workshop on 7th April at 11am EST / 4pm GMT. At this workshop, we will present an initial view on the documents and possible mappings and to consider any potential impact on the Reference Model. This will then be fed back to the Change Control Board for formal assessment within their Zone teams.
If you would like to join and actively contribute to these discussions, please pre-register here: https://us06web.zoom.us/meeting/register/tZwrceCpqTMiHtKDA-k4A_bydzUOvAPpSd_h. After registering, you will receive a confirmation email containing information about joining the meeting.
IMPORTANT NOTE: This workshop is intended solely for participants who will actively contribute thoughts and opinions. Please do not register simply to listen in. Thank you!
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