ICH-GCP only uses the word “signed” in relation to 5 TMF documents:
- protocols and amendments;
- 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”.
Whilst there may be local/national legal requirements for certain documents to be wet-ink signed, there is no requirement in GCP regulations for signed documents to be signed using wet-ink. Electronic signatures are acceptable and equivalent to wet-ink signatures as long as they meet the corresponding regulatory requirements for electronic signatures and use of computerised systems.