224 - Project Revision/Amendment Form



| |Humanitarian Use Device |

| |Progress Report |

| | |

| |Florida Hospital Tampa Bay Division IRB |

| |Continuing Review / Final Report |

|Full Board Continuing Review Instructions: |Expedited Continuing Review Instructions: |

|Submission deadline: Due on the 1st of the month for review on the 3rd |Guidance for HDE Holders recommends that Continuing Review of Humanitarian Use |

|Tuesday. |Devices be conducted by Expedited Review. |

|Submissions should be provided to the IRB as follows: | |

|Via electronic format; or, |Section 47: |

|17 collated paper copies | |

| |GuidanceDocuments/ucm110194.htm |

|Continuing Review Application: The form must be filled out completely, and signed. Please note that blanks and/or insufficient information may result in a delay of|

|your review/approval. |

|Contact Information: |

|Today's Date:       |Date of Initial Review:       |Date of Last Continuing Review:       |

|Type of Submission: | Continuing Review | Final Report – Termination requested |

|Type of Review Requested: | Full Review | Expedited Review |

|Humanitarian Use Device (HUD) Exemption | |

|#: |      |

|Device Name - Trade: |      |

|Device Name - Generic: |      |

|Device Sponsor: |      |

|Physician Approved for use: |      |

|Primary Contact: |      |E-mail: |      |

|Telephone: |      |Fax: |      |

|Status of Device Renewal: |

|If no longer seeking approval for continued use of the device, select “Final Report - Termination Requested”. The form must be completely filled out, including |

|available safety information and applicable plans for research and/or commercial development. |

| Requesting Renewal | Final Report - Termination Requested |

|Summary of Device Usage: |

|Site: | |Total Devices Used Since Last Continuing |

| |Total Devices Used Since IRB |Review: |

| |Approval: | |

| Florida Hospital Tampa |      |      |

| Florida Hospital Pepin Heart Institute |      |      |

| Florida Hospital Carrollwood |      |      |

| Florida Hospital Zephyrhills |      |      |

| Florida Hospital Connerton (LTAC) |      |      |

| Florida Hospital North Pinellas |      |      |

| Florida Hospital Wesley Chapel |      |      |

|Total Device Usage |      |      |

|Summary of Product Information and Indications for Use Since Last Continuing Review: |

|Any revisions to the indications for use? Yes No |

| |

|If yes, please describe new indications:       |

|Was the device used outside its approved indications for use? Yes No |

| |

|If yes, describe the use and justification for off-label use:       |

| |

|Was the IRB notified of the off-label use: Yes No |

| |

|If no, please provide a brief summary of the reason the IRB was not notified:       |

|Summary of Informed Consent Since Last Continuing Review: |

|Did the IRB require use of an Informed Consent form? Yes No |

|*If yes, please select the applicable informed consent status |

| Informed Consent Form (no change) |Current Use consent form version -       |

| New Revised Informed Consent Form |New consent form version -       |

|If Informed Consent was waived by the IRB, was the manufacturer patient information provided to the patient(s) prior to use of the HUD, with appropriate review and |

|explanation? Yes No |

| |

|If no, please provide an explanation of the omission:       |

|Summary of New and/or Revised Product Information Since Last Continuing Review: |

|*Include new and/or revised material |

| FDA Status Change |Describe:       |

| Manufacturer Product Labeling |Describe:       |

| Clinical Brochure |Describe:       |

| Manufacturer Provided Patient Information |Describe:       |

| Safety and/or Benefit Information |Describe:       |

| Product Information |Describe:       |

| Publications |Describe:       |

| Periodic Reports |Describe:       |

| Other |Describe:       |

|Comments:       |

|Summary of Adverse Events Since Last Continuing Review[i]: |

| |

|Number of adverse events (at any site) requiring submission to the IRB: |

| Florida Hospital Tampa |      |

| Florida Hospital Pepin Heart Institute |      |

| Florida Hospital Carrollwood |      |

| Florida Hospital Zephyrhills |      |

| Florida Hospital Connerton (LTAC) |      |

| Florida Hospital North Pinellas |      |

| Florida Hospital Wesley Chapel | |

|Any unanticipated problems involving risks to patients? | |

|If yes, please explain:       |Yes* No |

|Any deaths involved with use of the device? |Yes* No |

|Was the death related to the device? |Yes* No |

|Please describe the event and its relation to the device:       | |

|Have any patients or others complained about the device? | |

|If yes, please summarize (include relevant documents):       |Yes* No |

|Have any obvious benefits occurred for patients receiving the device? | |

|If yes, please summarize (include relevant documents):       |Yes* No |

|Have any risks or potential benefits for this device changed? | |

|If yes, please summarize (include relevant documents):       |Yes* No |

______________________________ _________ ________ ___ ___________ ____________________

Signature of Principal Physician Approved for Use Date

-----------------------

END NOTES

| |

|[i] Serious Adverse Event Reporting |

|Events that occur at Florida Hospital Tampa Bay Division must be reported within 10 working days after the event is known to the investigator, or within 48 hours |

|if the event involves a death. |

| |

|Definition: |

| |

|A Serious Adverse Event (SAE) includes death, life threatening events, hospitalization or prolongation of hospitalization, disability or incapacitation, overdose, |

|congenital anomalies and any other serious events that may jeopardize the health or well-being of the subject or require medical or surgical intervention to |

|prevent one of the outcomes listed in this definition. |

|Serious Adverse Events and deaths must be reported to the FDA and the IRB: 21 CFR 803 |

| |

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download