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Hi there, I just realized that the ICH-GCP essential documents list has the following item as required for site and sponsor:
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.
I have always been aware of the need to collect PROTOCOL signature page (although I think the content is typically covered in the contract/clinical trial agreement anyway). However, so far I have not been aware a SAMPLE CRF signature is also needed. Upon checking the reference model, I cannot find it explicitly listed either (in contrast to the protocol signature page). I am curious on other people’s experience: Are you collecting these? If not, what is your rationale. If yes, where do you file them and who signs them? Should this be added to the reference model?
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Hi Anke
In general, each artifact in the Reference Model also includes any associated approvals.
Eldin.
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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.
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I’ve never seen a PI signature for a sample CRF, if that’s what you’re asking. I’ve only seen/filed the internal approval signature for the sample CRF.
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