Monday July 4th all principle investigators with an account in de METC module of Research Manager will receive an activation e-mail providing them direct access to their digital trial file (TMF/ISF) in the Studymanagement Module. Thereafter you may add studyteam members to the digital file at will.
The Studymanagement module is linked to the METC module. When a submitted research protocol receives approval from the MERC and/or Hospital Board, automatically a file is created for that specific trial in the Studymanagement module. This is the basis for your digital file, providing you with insight in the most recent documentation and the possibility to keep track. For the duration of the trial your digital file is supplemented with general data and approved documents (safety reports, amendments) from the METC module so you only have to submit that information and documentation once. You will also be able to add other study-related documentation.
Please find the manual for researchers and the landing page where you can login to one of the both modules of Research Manager or request for an account.
Should you have any questions please contact CMC at: cmc_diensten@amsterdamumc.nl