Hi Eldin,
Thanks for your reply. GCP does not seem to refer to an (internal) approval, but specifically to an investigator signature to confirm they agree to the template CRF.
GCP mentiones protocol and CRF signature page in the same sentence (“SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF)”. To document investigator and sponsor agreement to the protocol/amendment(s) and CRF.. However, the set-up in the reference model is different for them:
– For the protocol, there are artifacts for the signature pages
– For the CRF, there is no artifact for the signature page.
When 2 documents are mentioned with the same requirements in the same sentence, I would be expecting they are treated the same in the reference model, too.