FDA not tracking investigator financial interests
- use a complete list of clinical investigators to check that sponsors have submitted information for all clinical investigators;
- check that sponsors have submitted all required attachments to financial forms;
- update guidance to sponsors on the due diligence exemption;
- add a review of financial information to the onsite inspection protocol;
- require that all Centers consistently use a template including a prompt to document a review of financial information;
- provide additional guidance and training to reviewers; and
- require that sponsors submit financial information for clinical investigators as part of the pre-trial application process.