FORM: Continuing Review Progress Report for Humanitarian Use Device (HUD)

F221: Continuing Review Progress Report for Humanitarian Use Device (HUD)

Use for both continuing review and as a final report to close a study. Please do not submit amendments with this form, instead use a F222 IRB Project No.: Previous Expiration Date: Project Title: Physician: Physician's Contact Phone/Official University Email: Information: Alternate Contact: Alternate Contact's Phone/Official University Email: Information:

SECTION 1: ABSTRACT OF THE HUMANITARIAN USE DEVICE:

SECTION 2: CURRENT PROTOCOL STATUS Check all that apply a. No patients were ever enrolled and the HUD will not be used (NOTE: The project will be concluded). b. Enrollment in progress or still planned. c. The HUD is permanently closed to enrollment. d. All patients have completed all interventions. e. HUD is permanently closed to enrollment AND all patients have completed all interventions (NOTE: The project will be concluded) f. This project was administratively closed and this submission is to resolve the administrative closure.

SECTION 3: ENROLLMENT STATUS: Total number of subjects enrolled: Since Since last Male Female Other/Unknown activation: approval: (total) (total) (total) Total locally: Total all sites (if available):

of 3 HSPP Use Only: Form 221 v2016-07 SECTION 4: STATUS REPORT ON THE PROGRESS OF THE HUD:

SECTION 5: QUESTIONNAIRE:  For Questions 1-9, attach a summary explanation or description for each question whose answer is "Yes." Summaries are not required for "No" answers.  "Last IRB review" means an initial or continuing review, whichever is most recent. YES NO 1. Since the last IRB review, have patients experienced any harm (expected or unexpected)? 2. Since the last IRB review, have patients experienced any benefits? 3. Since the last IRB review, have there been any reportable information items since the last IRB review? 4. Since the last IRB review, have any patients withdrawn or stopped use of the HUD? 5. Since the last IRB review, has there been any relevant information, including publications in the literature relevant to the risks or potential benefits of the HUD? 6. Since the last IRB review, have there been any amendments to the research? Date of IRB Approval Brief description of amendment

7. Since the last IRB review, has the status of the HUD for the device changed? 8. Since the last IRB review, has the HUD been used for a purpose outside its approved indication (i.e. off-label for emergency or compassionate use)?

LIST OF ATTACHMENTS FOR THIS SUBMISSION Document Name Version Date 1. 1.

Department Head or Designee Approval (NOT required for HUDs being concluded) I have reviewed this form and determined that all departmental requirements are met and that the physician has appropriate resources to use the Humanitarian Use Device. Departmental Chair or Supervisor Signature Date

of 3 HSPP Use Only: Form 221 v2016-07 Physician Acknowledgement I agree to conduct this Human Research according to the University of Arizona HSPP policies and procedures for research with Human Subjects. Investigator signature Date

See HSPP website for submission requirements Provide 1 copy of the following:  If the IRB has required, the use of a consent form; stamped consent documents (unsigned) that have been used during this approval period.  If the IRB has required, the use of a consent form; consent documents to be used in the next approval period. (This may be omitted if the HUD is being concluded.)  A script of information to be provided orally to subjects if consent will not be documented in writing. (This may be omitted if the HUD is being concluded.)  Summary regarding any "Yes" answers from Section 5; questions 1-9 above.

of 3 HSPP Use Only: Form 221 v2016-07