REQUEST FOR Compassionate Use of an

Investigational Device for a Serious Disease or Condition

DATE
Principal Investigator (PI)
(Last, First, Credentials)

PI Employer(“x” appropriately)

/ [] WU [] BJH [ ] SLCH
[] Other: (All non-WU staff must complete an “Unaffiliated Investigator Agreement.”
Please contact the HRPO office for more information.)

Division / Department

/

Dept Billing #

PI’s Address/Box /

Phone #

Email address

/

FAX

Administrative Person
(Receives copies of the paperwork) /

Box #

Email address

/

Phone #

Study or Regulatory Coordinator

(Can answer protocol questions) /

Box #

Phone #

Drug / Device / Procedure

/

IND/IDE #

Performance Site

Sponsor

(Call 362-6869 regarding indemnification agreement)

Title
(Protocol title must match the NIH/Sponsor title)

PRMC does not review this form because no scientific question is asked.

This request is FDA-regulated so data related to this treatment may be reported to a sponsor and the FDA. Data may not be used for your own prospective research.

______

Signature of Physician Date

Compassionate Use of an Unapproved Device for a Serious Disease or Condition

  1. Provide a description of the patient’s condition and the circumstances necessitating treatment. Include the treatment plan.
  1. Describe why alternatives therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.
  1. If there is an IRB approved protocol, describe what deviations or alterations from the protocol are necessary in order to treat the patient.
  1. Describe the plan to monitor the patient to address the specific needs of the patient and detect any possible problems.

5. What is the status of the device? (check which one applies)

[ ]There is no Investigational Device Exemption (IDE)

-Prior to use of the device you must obtain approval from the FDA to use the device for this purpose.

[ ]We would like to use the device in a way not approved under an existing IDE (patient does not meet inclusion criteria or is otherwise not eligible)

-Prior to use of the device, you must obtain approval from the sponsor (IDE holder).

-Prior to use of the device, you must obtain FDA approval to use the device for this purpose.

[ ]The treating physician is not part of the IDE study

-Prior to use of the device, you must obtain approval from the sponsor (IDE holder).

-Prior to use of the device, you must obtain FDA approval to use the device for this purpose.

6. Consent is required from the participant or legally authorized representative. Provide a copy of the consent form.

7. Once submitted, the IRB Chair may require an independent assessment from an uninvolved physician concurring with this request. This assessement can be provided in writing, signed and dated by the uninvolved physician, or can be communicated via an email from the uninvolved physician.

8. Once FDA approval is obtained this should be submitted to HRPO. This can be submitted via email to Jennifer Gartland at .

9. Following the use of the device:

-Submit a follow-up report to HRPOif any problems occurred as a result of device use. These should be reported as soon as possible (report this via Form 15).

FDA Guidance for the COMPASSIONATE USE OF AN UNAPPROVED DEVICE FOR A SERIOUS MEDICAL CONDITION OR DISEASE

Version Date: 2013.10.14