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PART I - BACKGROUND

This compliance program is one of four agency-wide Bioresearch Monitoring Compliance Programs. Regulations that govern the proper conduct of clinical studies establish specific responsibilities of sponsors for ensuring (1) the proper conduct of clinical studies for submission to the Food & Drug Administration (FDA) and (2) the protection of the rights and welfare of subjects of clinical studies. The specific regulations are found in 21 CFR 312 (CBER and CDER), 21 CFR 812 (CDRH), and 21 CFR 511.1(b) (CVM). The specific responsibilities of sponsors of clinical studies include obligations to:

    1. Obtain agency approval, where necessary, before studies begin.
    2. Manufacture and label investigational products appropriately.
    3. Initiate, withhold, or discontinue clinical trials as required.
    4. Refrain from commercialization of investigational products.
    5. Control the distribution and return of investigational products.
    6. Select qualified investigators to conduct studies.
    7. Disseminate appropriate information to investigators.
    8. Select qualified persons to monitor the conduct of studies.
    9. Adequately monitor clinical investigations.
    10. Evaluate and report adverse experiences.
    11. Maintain adequate records of studies.
    12. Submit progress reports and the final results of studies.

Sponsors may transfer responsibility for any or all of these obligations to Contract Research Organizations (CROs). [Note: The medical device regulations (21 CFR 812) do not define or delineate responsibilities for CROs.] Under the regulations such transfers of responsibility are permitted by written agreement. Responsibilities that are not specified in a written agreement are not transferred. When operating under such agreements, the CROs are subject to the same regulatory actions as sponsors for any failure to perform any of the obligations assumed.

Monitors are employed by sponsors or CROs to review the conduct of clinical studies to assure that clinical investigators abide by their obligations for the proper conduct of clinical trials.

A Sponsor-Investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational article is administered, dispensed or implanted. The requirements applicable to a sponsor-investigator include both those applicable to an investigator and a sponsor. See CP 7348.811 for Clinical Investigators.
Hypertext updated April 5, 2001 tmc