ICH-GCP only uses the word “signed” in relation to 5 TMF documents:
- protocols and amendments;
- agreements/contracts;
- completed consent forms;
- completed case report forms;
- and CRF correction signature sheet / signature log.
The MHRA have stated in the GCP Guide that “signatures on documents are recommended only where it adds value”.
May 17, 2103
Trial Master File Reference Model 