The complete file must be submitted to the FAMHP via CESP. The FAMHP will validate the file within 5 days of receipt. Note that the procedure does not allow for validation questions, for example, if the file lacks the PMCF plan, the study will be rejected automatically.
If the file is complete, the CT College sends it to an independent EC.
In other words, these studies cannot be submitted directly to the EC Research.
The following type of study needs to be submitted according to this pathway:
➔ PMCF study involving additional burdensome or invasive procedures