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!