An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB/IEC. In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?
Correct answer:
A
The protocol signature page documents agreement between the sponsor and the investigator/institution to conduct the trial in compliance with ICH GCP, the protocol, and regulatory standards.
ICH E6(R2) 8.2.2 (Signed protocol and amendments): Requires ''the sponsor and investigator/institution to sign the protocol and amendments, confirming agreement.''
ICH E6(R2) 4.5.1: ''The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, approved by the regulatory authority(ies) and by the IRB/IEC.''
The sponsor--investigator signatures ensure shared accountability for subject protection, data integrity, and adherence to trial methodology. Neither delegated staff (B) nor IRB/IEC (C) nor FDA (D) sign protocols. These bodies approve or oversee, but do not formally enter into execution of the protocol.
Thus, the correct answer is A (The investigator/institution and the sponsor).
ICH E6(R2), 8.2.2 (Signed protocol and amendments).
ICH E6(R2), 4.5.1 (Investigator compliance with protocol).