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PD 300: Protocol Development

SOP No.: 300         PROTOCOL DEVELOPMENT
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:  Any investigation product (drug, biologic, medical device)
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. 301: Clinical Protocol Development, Implementation and Compliance

This procedure describes the process for developing, reviewing, approving and implementing clinical protocols and includes all human subject research that is conducted using an FDA-regulated product whether or not there is an IND or IDE in place.

SOP No. 302: Clinical Protocol Amendments

This procedure describes the process for developing, reviewing and approving protocol amendments that will be used for conducting a clinical study intended to collect safety and/or efficacy data on an unapproved use of a new drug, biologic or medical device (the investigational product).

SOP No. 303: Investigator’s Brochure

This procedure provides a process for developing, reviewing, approving and distributing Investigator Brochures or similar documents that are intended to inform participating Investigators about the investigational product(s) they will be using in an FDA-regulated human subject research study.