Emory IRB Protocol Outline For Protocols using a HUD for Treatment Purposes Full study title: Principal Investigator: Department: HUD Holder: Summary of use: Proposed treatment: Patient selection: Patient consent to treatment: NOTE: The treating physician must document that they have provided this information sheet and taken time to go over it with the patient. This should be documented in the patient medical record or treatment record. Device storage: References , Chapter 68 (Humanitarian Use Devices: Exemptions & Uses) FDA FDA guidance:
Emory IRB Protocol Outline For Protocols using a HUD for Treatment Purposes Full study title: Principal Investigator: Department: HUD Holder: Summary of use: Proposed treatment: Patient selection: Patient consent to treatment: NOTE: The treating physician must document that they have provided this information sheet and taken time to go over it with the patient. This should be documented in the patient medical record or treatment record. Device storage: References , Chapter 68 (Humanitarian Use Devices: Exemptions & Uses) FDA FDA guidance:
HUD-Treatment-Protocol-Outline.docx