Every artifact that is specifically identified in chapter 8 of ICH GCP has the relevant citation listed. In addition, where text elsewhere in the ICH guideline refers to a trial artifact, that citation has also been listed. For example, ICH section 4.12 discusses the need for the investigator to notify the IRB/IEC of trial termination. Therefeore, 4.12 is cited against artifact 03.03.03 ‘Notification of Trial Termination’ in the Reference Model.
July 2, 2014
Category: FAQs
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.