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Clinical Investigator Responsibilities -- Protecting the Rights, Safety and Welfare of Study Subjects
by Edward M. Basile
King & Spalding LLP - Washington Office
Beverly Lorell
King & Spalding LLP - San Francisco Office
Christina M. Markus
King & Spalding LLP - Washington Office
Elaine H. Tseng
King & Spalding LLP - San Francisco Office
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November 6, 2009
Previously published on November 5, 2009
The Food and Drug Administration (FDA) posted a final guidance in October 2009 to clarify the responsibilities of investigators in conducting clinical trials of drugs, biological products and medical devices. The final guidance reiterates the scope of responsibilities set forth in a May 2007 draft guidance, while modifying certain recommendations related to an investigator's supervision of other parties and ensuring reasonable access of subjects to medical care.
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The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance. |
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