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Hi Anke
It is here under TMF Tools: https://tmfrefmodel.com/resources
KarenThe 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!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!Hi Janet
The regulations state that if you have paper originated documents that you destroy, the copies should be certified. If you have the files electronically, you could use these and not scan and certify, but I would personally assess the effort of just scanning all the documents from paper (certified process) versus scanning some and finding some electronic and filing the electronic ones in between the scanned paper documents!
In addition, you need to be sure that the electronic documents have not been changed over the years.
KarenHi Mariz. If you look under resources you will find an email communication guide and webinar recording – these will help!
KarenHi Katie
There are a number of slides that the MHRA have presented that support that section 8 is not sufficient. They may help – email me and I can send them. kroy@phlexglobal.com
Karen
Hi Janna
Can I advise that you look at TMF RM 3.2 with the new set of sub-artifacts? This will assiste with where to file documents.
Karen
Hi
Assuming there is still a Sponsor funding the project, I would put the CVs in Zone 9. If the CRO is also the Sponsor, then Zone 1.
KarenHi Michelle
The best thing is to talk to people who have moved to an eTMF already. Many people have presented at conferences. I’m sure people will offer on here! Feel free to email me and I can send on any presentations I can find kroy@phlexglobal.com.
Karen