What must an investigator submit to the sponsor if they are involved in a new protocol?

When an investigator is involved in a new protocol, submitting a new Form FDA 1572 is essential. The Form FDA 1572 is a critical document that provides the sponsor with the necessary information regarding the investigator and the site. It outlines the investigator's qualifications, responsibilities, and the facility's capabilities to conduct the clinical trial.

This form is required by the FDA for all clinical investigations of products regulated by the agency and must be updated whenever there is a change in the study protocol or investigator. This ensures that sponsors and regulatory bodies maintain current and accurate information about the trial.

While the other options may relate to different clinical trial processes, they do not fulfill the immediate requirement of necessary documentation for an investigator participating in a new protocol. For instance, a final study report is usually submitted at the end of a study to summarize findings, while a financial audit report pertains to the financial aspects of the study, and a proposal is typically part of the initial planning phase before a trial is initiated. Thus, the Form FDA 1572 is the correct answer in this context.