Gene Therapy Full Submission Checklist

Checklist: Gene Therapy, New, Convened Review

No two-sided copies, please Please use paper clips and/or rubber bands, not staples

One copy of the completed and signed IRB Human Subjects Protocol

One copy of the signed Protocol Oversight Review Form

One copy of the Report of the Gene Therapy Project Review Panel. The panel must also address the Children’s Risk Level Assessment in a memorandum, if applicable

For research involving (a) children and/or minors less than 19 years of age; (b) pregnant women, fetuses, and neonates; or (c) prisoners, the appropriate Special Population Review Form

One copy of the Consent Form

 Make sure you have checked the IRB web page (www.uab.edu/irb) for the most current consent form format

If applicable, one copy of “special approvals,” which are addressed in Section 5 of the Guidebook and include:

 Release of Drugs for Human Research Use pharmacy form (required for drug studies being conducted at UAB, TKC or Children’s Hospital),  Radiation Safety approval,  Release of Pathologic Materials form (Anatomical or Clinical Pathology)  Infection Control memorandum,  Approval from The Kirklin Clinic, University Hospital, The Children’s Hospital of Alabama and/or Callahan Eye Foundation Hospital,  Documentation/verification of the sponsor’s injury compensation policy, if applicable  Sponsor Billing Form, if industry sponsored,  Waiver of Compliance Billing Language, if applicable.

One copy, if applicable, of the sponsor’s protocol and/or the Funding Application (grant, letter requesting funding, etc.).

One copy of the Investigator’s Brochure for studies using an investigational new drug or the package insert for studies using commercially available drugs in an investigational manner and one copy of the FDA 1572 form.

 Failure to follow the above instructions for submission will delay review of the protocol.

Mail or deliver all IRB materials and correspondence to Room 470, Administration Building (AB) 701 20th Street South, Birmingham, AL 35294-0104 Phone 205-934-3789 — Fax 205-934-1301

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