Have you ever done a regulatory review and noticed a protocol signature page that wasn’t signed by the Principal Investigator? Or, have you seen a protocol that does not have a signature page? It may make you wonder if a signature page is required.
The FDA does not have a regulation that requires the Principal Investigator to sign the protocol for either drug or device studies.
For drug studies, a 1572 form is completed by the entire study team indicating that they agree to follow the protocol and applicable federal regulations. For device studies, investigators sign an Investigator Agreement which contains similar language.
However, ICH GCP E6 8.2.2 states that a signed protocol and amendments should be retained as essential documents to conduct the study in both the investigator and sponsor files. The purpose is to document the investigator and sponsor’s agreement to follow the protocol.
Since it is not a FDA requirement, the PI does not have to sign off on the protocol per federal regulations. Sponsors may add the signature page to comply with Good Clinical Practice. As for protocol amendments, it is a good way to document the PI has received, reviewed and agrees to follow the changes to the updated protocol. 1572s and Investigator Agreements are generally not updated with protocol changes.
And as always, although the FDA does not require the PI to sign the clinical investigational plan, it may be a requirement of the Sponsor or IRB. In which case, this requirement must be followed.
Did you know that signatures were not required on protocols? If the protocol is not signed, what are some ways to show receipt and understanding of the protocol?
Photo Credit: LucasTheExperience