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GA 100: General Administration

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 SOPs used in FDA-regulated human subject research within 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. 101: Standard Operating Procedure (SOP) Preparation & Maintenance

This procedure describes the necessary steps for developing, revising and maintaining standard operating procedures (SOPs) for Food and Drug Administration (FDA)-regulated human subject research regardless of whether an IND or IDE is in place.

SOP No. 102: Document Development and Change Control

This procedure describes the steps to be followed for developing, revising and approving controlled and non-controlled documents for FDA-regulated human subject research documentation regardless of whether an IND or IDE is in place.

SOP No. 103: Investigator Responsibility and Delegation of Responsibility

This procedure defines the responsibilities of the Investigator, both as a Sponsor of FDA-regulated human subject research, and as an Investigator conducting that research. It also identifies areas of accountability and the process for delegating the transfer of the Investigator's responsibilities to other designated individuals.

SOP No. 104: Study Team Training

This procedure describes the process for conducting training of the Investigators and other designated individuals who participate in the conduct of FDA-regulated human subject research.

SOP No. 105: Prohibition of Financial Conflicts

This procedure relates to financial conflicts of interest of Clinical Investigators engaged in the conduct of FDA-regulated human subject research and the steps that must be taken to report such conflicts to the IRB, Thomas Jefferson University, and if applicable, FDA regulatory authorities.