Clinical investigators subject to investigational new drug or investigational device exemption regulations must provide the sponsor of the study with sufficient accurate information needed to allow subsequent disclosure or certification. Thus, all references to “sponsor” in this part apply to a contract research organization to the extent that it assumes one or more obligations of the sponsor. In compliance with the u.s
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Code of federal regulations 21cfr54, clinical investigators are required to disclose to the study sponsor their financial interests for the period of time he or she participated in the study and for one year following the end of his or her participation in the study.
Fill out a separate financial disclosure form for each entity that could be considered a sponsor for this study
For questions, refer to the fda guidance Financial disclosure by clinical investigators or contact the office of regulatory affairs and quality at oraq@duke.edu. If a spouse or dependent child is an employee of the sponsor, the clinical investigator should be identified as an employee of the sponsor and no further disclosure is required (21 cfr § 54.4.). This document is a revision of the guidance for industry
Financial disclosure by clinical investigators dated march 20, 2001. Academic investigators sometimes equate the term “sponsor” with the source of the study funding In fact, there are two types of sponsors Regulatory sponsor and financial sponsor.
