Which TMF documents require a signature?

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”.

ADDENDUM:

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.

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