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RA-200: Regulatory Affairs

Author:    Office of Human Research
Effective Date:  October 1, 2007 Supercedes document dated:              N/A
Last Reviewed on:     N/A                                  Results of Review:               N/A
This SOP pertains to:  All personnel involved in corresponding with FDA and in developing submissions pertaining to FDA-regulated human subject research within the Thomas Jefferson University
Responsibility for executing this SOP:  Investigator and Designated Research Personnel
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)

SOP No. 201: Contacts and Submissions for FDA

This procedure outlines the process for conducting effective correspondence with the FDA, both oral and written, for conducting meetings with the agency, and for preparing certain formal submissions to the agency.

SOP No. 202: Reporting Requirements for the FDA under an IND or IDE

This procedure describes the process and requirements for preparing, distributing and maintaining FDA-required reports on the conduct of FDA-regulated human subject research.

SOP No. 203: NIH Requirements for OBA-reviewed research

This procedure serves as a companion to SOP 201, Contacts and Submissions for the FDA and SOP 202, Reporting Requirements for the FDA. It describes additional regulatory submission and reporting requirements associated with The Office of Biotechnology Activities (OBA)-reviewed research that must be provided to the OBA Recombinant DNA Advisory Committee (RAC) before such research can begin in human participants, and while such studies are underway.