Q31: Please list the Financial Disclosure Requirements of the FDA?
Answer:
Under the applicable regulations (21 CFR Parts 54, 312, 314, 320, 330, 601, 807, 812, 814, and 860), an applicant is required to submit to FDA a list of clinical investigators who conducted covered clinical studies and certify and/or disclose certain financial arrangements as follows:
1. Certification that no financial arrangements with an investigator have been made where study outcome could affect compensation; that the investigator has no proprietary interest in the tested product; that the investigator does not have a significant equity interest in the sponsor of the covered study; and that the investigator has not received significant payments of other sorts; and/or
2. Disclosure of specified financial arrangements and any steps taken to minimize the potential for bias.
Disclosable Financial Arrangements:
1. Compensation made to the investigator in which the value of compensation could be affected by study outcome. This requirement applies to all covered studies, whether ongoing or completed as of February 2, 1999.
2. A proprietary interest in the tested product, including, but not limited to, a patent, trademark, copyright or licensing agreement. This requirement applies to all covered studies, whether ongoing or completed as of February 2, 1999.
3. Any equity interest in the sponsor of a covered study, i.e., any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices. This requirement applies to all covered studies, whether ongoing or completed;
4. Any equity interest in a publicly held company that exceeds $50,000 in value. These must be disclosed only for covered clinical studies that are ongoing on or after February 2, 1999. The requirement applies to interests held during the time the clinical investigator is carrying out the study and for 1 year following completion of the study; and
5. Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator 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 completion of the study. This requirement applies to payments made on or after February 2, 1999.
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