Significant payments of other sorts

These payments have to be disclosed under 21 CFR Part 54 because they could bias a covered study. Grants, equipment and honoraria all count, so record-keeping has to start when the study starts, not at submission.

Significant payments of other sorts means payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more than $25,000, exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following the completion of the study.

21 CFR, 54.2