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Clinical Trial Submission Instructions

For full IRB review, submit 20 stapled, collated packets of the FH/IRB-1, FH/IRB-2, FH/IRB-3, FH/IRB-4 (consent form) and all supplemental materials (e.g., advertising, recruitment letters, questionnaires, etc.). For expedited review or exemption request, submit 3 packets. Provide 4 copies of the sponsor protocol if commercially sponsored, 4 copies of the grant if federally funded, or 4 copies of the investigator-written protocol if unfunded. For a study involving investigational drug(s)/device(s), include 4 copies of the investigational drug/device brochure(s). If the study involves a drug(s)/device(s) that is not investigational, include 4 copies of the package insert(s). Please forward all materials to:

Elizabeth M. Medina, RN, BSN, CCRN
Administrator, Institutional Review Board
Frankford Hospitals
Mansion House, 2nd floor
Red Lion & Knights Rd.
Philadelphia, PA 19114