Who designs the protocol?

Who designs the protocol?

• A. CRO.
• B. Sponsor.
• C. Ethics Committee.
• D. Principal Investigator.

Answer: (B)

The protocol is designed by the sponsor. The sponsor initiates and funds the trial and owns the protocol, which lays out the study’s objectives, design (including population, interventions, and endpoints), statistical plan, and safety monitoring. The Principal Investigator at a site carries out the study and can offer practical input, but does not create the governing protocol. The Ethics Committee reviews the protocol for ethical safeguards and participant protection, not its design. A CRO may help run the trial and even contribute to drafting, but ultimate responsibility and ownership of the protocol lie with the sponsor.

The protocol is designed by the sponsor. The sponsor initiates and funds the trial and owns the protocol, which lays out the study’s objectives, design (including population, interventions, and endpoints), statistical plan, and safety monitoring. The Principal Investigator at a site carries out the study and can offer practical input, but does not create the governing protocol. The Ethics Committee reviews the protocol for ethical safeguards and participant protection, not its design. A CRO may help run the trial and even contribute to drafting, but ultimate responsibility and ownership of the protocol lie with the sponsor.