AN HUD MAY BE ADMINISTERED TO A PATIENT ONLY IF APPROVE BY THE CONVENED (FULL) IRB, unless there are exceptions of certain emergencies where prior IRB approval is not required under applicable FDA regulations. For information on emergency use of a HUD, please see Policy IRB-01. Submission Checklist (REQUIRED): All required applicable materials and all required signatures must be submitted or the IRB application package cannot be processed. IRB forms and templates are available on the or on the and Templates” button on the left menu in . “Forms required for all new submissions: Registration Form. Application for External IRB (this form). HUD FDA Approval Letter or documentation HUD Protocol from manufacturer HUD Patient Information booklet from manufacturer HUD Package Insert/Labeling Information HUD Safety of efficacy data provided by manufacturer These above HUD documents should be available from manufacturer or on the FDA website at: GENERAL INFORMATION Title: Principal Clinician: Dept: Contact Information: Phone # (required): (required): Alternate E-mail (optional):
AN HUD MAY BE ADMINISTERED TO A PATIENT ONLY IF APPROVE BY THE CONVENED (FULL) IRB, unless there are exceptions of certain emergencies where prior IRB approval is not required under applicable FDA regulations. For information on emergency use of a HUD, please see Policy IRB-01. Submission Checklist (REQUIRED): All required applicable materials and all required signatures must be submitted or the IRB application package cannot be processed. IRB forms and templates are available on the or on the “Forms and Templates” button on the left menu in . required for all new submissions: Registration Form. Application for External IRB (this form). HUD FDA Approval Letter or documentation HUD Protocol from manufacturer HUD Patient Information booklet from manufacturer HUD Package Insert/Labeling Information HUD Safety of efficacy data provided by manufacturer These above HUD documents should be available from manufacturer or on the FDA website at: GENERAL INFORMATION Title: Principal Clinician: Contact Information: Phone # (required): (required): Alternate E-mail (optional): Dept: