What must the investigator/institution do to confirm agreement with the sponsor?

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Multiple Choice

What must the investigator/institution do to confirm agreement with the sponsor?

The key action is for the investigator (or the institution) to sign the document that defines the study—typically the protocol or an equivalent contract. Signing these documents formally expresses mutual agreement to conduct the trial as outlined, and it binds both sides to the responsibilities, procedures, and regulatory obligations described. A signature on the protocol shows the investigator’s commitment to follow the plan and comply with Good Clinical Practice and applicable laws, while the sponsor’s signature confirms their obligation to provide the investigational product and oversight. Circulating information to participants, notifying regulatory authorities, or requiring sponsor approval for every change happens after this initial agreement and relates to communication, regulatory duties, or change control, not to the initial confirmation of mutual agreement between sponsor and investigator.

The key action is for the investigator (or the institution) to sign the document that defines the study—typically the protocol or an equivalent contract. Signing these documents formally expresses mutual agreement to conduct the trial as outlined, and it binds both sides to the responsibilities, procedures, and regulatory obligations described. A signature on the protocol shows the investigator’s commitment to follow the plan and comply with Good Clinical Practice and applicable laws, while the sponsor’s signature confirms their obligation to provide the investigational product and oversight.

Circulating information to participants, notifying regulatory authorities, or requiring sponsor approval for every change happens after this initial agreement and relates to communication, regulatory duties, or change control, not to the initial confirmation of mutual agreement between sponsor and investigator.

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