Physician
Physician Name, Degree(s):
Affiliation / UA B–UMG Other:
Physician UA NetID
Status/Rank:
Center:
Department:
Section:
College:
Contact phone:
Official University Email:
Alternate/Coordinatorcontact information
Name, UA NetID:
Contact phone:
Official University Email:
SECTION 1: SIGNATURES
1. Physician
I will conduct this work according to the FDA regulations regarding Humanitarian Use Devices.
Signature / Date / Print Name2. Department/Center/Section Review
I have reviewed this application and determined that all departmental requirements are met and that the physician has adequate resources to conduct the Humanitarian Use Device.
Signature / Date / Print NameSection 2: Humanitarian Use Device Information
- Does the protocol evaluate the safety or effectiveness of the HUD?
- Insert HUD Information
HUD Name / HDE # / Manufacturer
FDA Approved Indication
- Where will the HUD be stored?
- Where will the HUD be used?
Section 3. PROJECT NARRATIVE
Delete the red text prior to submitting this form to the IRB.
Do not be concerned by the length of this section. It is long only because it contains guidance and explanations which you will delete as appropriate.
Provide a lay summary for all items below.You may reference the title and page numbers for any items described in the protocol or other documents submitted with the application.
1)Consent/Permission/Assent process
Describe how the patient will be informed of the potential risks and benefits of the HUD and any procedures associated with its use.
2)Procedures involved in the use/implementation of the HUD
This section should explain the procedures in lay language.
Summarize how the device is to be used, including a description of any screening procedures, the HUD procedure, and any patient follow-up visits, tests or procedures.
SECTION 4: LIST OF ATTACHMENTS FOR THIS SUBMISSIONDocument Name / Version Date
See HSPP website for submission requirements
Required items:
- Current physician CVs or biosketch
- Copy of FDA's HDE approval
- A description of the device
- The product labeling
- The patient information packet that may accompany the HUD
- All written information related to the HUD to be provided to or meant to be seen or heard by patients
Other Approvals that may be required before submission:
- Scientific Review Committee letter (for cancer related projects - AZCC SRC; other units as applicable if the unit has a scientific review committee)
- Biosafety Review letter(for UA - Institutional Biosafety Committee)
- Compressed Gases Review letter (for UA - Research Instrumentation)
- Export Control Review
- Radiation Safety Review letter- needed regardless if the radiation device is approved and used standard of care
- Other Approval letters(e.g., any other access to external sites for research purposes and/or access to administrative records/samples)
Other Items as applicable:
- Informed Consent document
- Protocol- including all amendments/revisions, sub- or extension-studies
- Contract- complete or draft copy of contract including budget
- Data monitoring Charter and Plan
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