Office of Human Research
Page Title
SOP No.: 400 STUDY START-UP |
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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: Any investigation product (drug, biologic, medical device) |
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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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SOP No. 401: Investigator Selection
This procedure describes the process for identifying and qualifying potential candidates to serve as participating site Investigators for a Thomas Jefferson University Investigator.
This procedure describes the activities and processes of the initiation visit and site training for a new clinical study site participating in Food and Drug Administration (FDA)-regulated human subject research. It also may be used when a new protocol or a new Investigator is initiated.
