Covered Clinical Study - any study of a drug, biological product or device in humans submitted in a marketing application or reclassification petition, that the Applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product) or that make a significant contribution to the demonstration of safety.  An Applicant may consult with FDA as to which studies are subject to the financial disclosure requirements.

Clinical Investigator (Investigator) - any listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects.  The term also includes the spouse and each dependent child of the investigator.

Applicant - the party who submits a marketing application to FDA for approval of a drug, device, or biologic product.  The Applicant is responsible for submitting the appropriate certification and disclosure statements.  This is generally the pharmaceutical or industry sponsor, although occasionally it may be the Investigator.

Sponsor - the party supporting a particular study at the time it was carried out.  In most cases, the Applicant and sponsor will be the same entity.

Institution - for purposes of implementing FDA requirements under 21 CFR 54, Institution shall mean any research institute or facility participating in a clinical study where the Research Foundation for Mental Hygiene, Inc. (RFMH) is the contracting organization

For Covered Clinical Studies under  21 CFR 54 Investigators must be careful to include and to clearly identify in their disclosure any:

• Compensation affected by the outcome of clinical studies - compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.
• Significant equity interest - 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 one year following completion of the study.
• Proprietary interest in the tested product - property or other Financial Interest in the product including, but not limited to, a patent, trademark, copyright or licensing agreement.
• Significant payments of other sorts - payments made by the sponsor of a covered study to the investigator or an 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 of honoraria) during the time the clinical investigator is carrying out the study and for one year following the completion of the study.
  
  

Investigators and RFMH are responsible for reporting to the party who plans to submit a marketing application to FDA (“Applicant”) certification and disclosure statements covering the items required by 21 CFR 54 and described above in Section: Submission and Review of Disclosures. Typically the Applicant is a commercial sponsor. However, in the unlikely event that the Investigator and/or RFMH is the Applicant then the Investigator must consult with the appropriate Institutional Official to ensure that FDA requirements will be met.  Further information can be found at: