Significant equity interest in the sponsor of a covered study

Sponsors collect financial information from clinical investigators and disclose or certify it in marketing applications that rely on covered studies. The definition includes a dollar threshold for public companies and a time window that runs beyond the end of the study.

Significant equity interest in the sponsor of a covered study means any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a nonpublicly traded corporation), or any equity interest in a publicly traded corporation that exceeds $50,000 during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.

21 CFR, 54.2