Office of Human Research
Page Title
SOP No.: 800 QUALITY ASSURANCE |
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Author: Office of Human Research |
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Effective Date: October 1, 2007 |
Supercedes document dated: N/A |
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Last Reviewed on: N/A |
Results of Review: N/A |
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This SOP pertains to: All SOPs used in FDA-regulated human subject research within Thomas Jefferson University |
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Responsibility for executing this SOP: Investigator and Designated Research Personnel |
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Approved By:
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR) |
Approved By:
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR) |
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This procedure describes the process to follow for initiating or otherwise participating in a QA audit to assess compliance with applicable regulatory requirements and guidelines for conducting Food and Drug Administration (FDA)-regulated human subject research within Thomas Jefferson University.
This procedure describes the process for conducting business with representatives of the FDA before, during and after an inspection of FDA-regulated human subject or other related research within Thomas Jefferson University.
