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Compassionate Use of an Investigational Device Request Form / REFERENCE NUMBER #:
(Assigned by COMIRB)

Colorado Multiple Institutional Review Board

Campus Box F-490 Telephone: 303-724-1055 Fax: 303-724-0990

*Please contact the COMIRB before using this form: 303-724-1055

This form must be completed for each person who will be treated with the investigational device.

PLEASE NOTE THAT THIS FORM CANNOT BE USED FOR DRUGS

An Individual Patient Expanded Use Access (compassionate use) is the use of an investigational device on a human subject in a serious situation requiring treatment within the next 1-2 weeks where no standard acceptable treatment is available and where there is insufficient time to obtain COMIRB Full Board approval.

Note: Prior FDA approval is required before expanded access use (compassionate use) occurs. The sponsor is responsible for submitting an IDE Supplement (see 21 CFR 812.35a).

A.Review Dates

1. Date of Initial Submission:

2. Version Date:

B.Device Information

1. Project Title:

2. Device Name:

3. Disease or Condition to be treated:

C.Contact Information

Principal Investigator (Attending Physician)

Name:Department:

Employee # /Student # (or POI #): Phone #:

Rank:Cell #:

Campus Box or Mailing Address:

Pager #: Fax #:

E-Mail Address:

Co-Investigators (please provide phone # and e-mail address)

Name / Phone / E-Mail

Primary Contact

Name:Department:

Employee # (or POI #)Phone #:

Rank:Cell #:

Campus Box or Mailing Address:

Pager #: Fax #:

E-Mail Address:

List All Research Coordinators (please provide phone # and e-mail address)

Name / Phone / E-Mail

Administrator / Manager

Name:Department:

Title:Phone #:

Role:Cell #:

Campus Box or Mailing Address:

Pager #:Fax #:

E-Mail Address:

D.Sponsor

1. Funding Sponsor:Sponsor Project # (if applicable):

2. The Institution receiving funding is:

UniversityHospital / The Children’s Hospital / VAMC / UCD Anschutz campus
DenverHealthMedicalCenter / ColoradoPreventionCenter / Downtown Denver Campus (DDC)
Other (please list):

E.Performance Site

Site where device will be used:

UniversityHospital / The Children’s Hospital / VAMC / UCD Anschutz campus
DenverHealthMedicalCenter / ColoradoPreventionCenter
Other (please list):

1. Will the device be used / administered atDenverHealthMedicalCenter? Yes No

2. Denver VAMC? YesNo

3. If yes to either, clearance from the appropriate institution must be submitted with the COMIRB application for review

H.Patient Information

1)Patient initials:

2)Age of patient:

3)Relevant diagnoses:

4)Is this the first patient to receive this device under this IDE supplement? Yes No

  1. If no, please provide the previous COMIRB reference number:

5)Please provide a description of the patient’s condition and the circumstances necessitating treatment including why this is considered a serious condition:

I.Device Information

1)Name of device:

2)Manufacturer:

3)Route:

4)Date (to be) administered:

5)IDE number:

6)Person inserting / administering the device:

J.Requirements for Compassionate Use

1)Please provide a discussion of why alternative 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:

2)Please identify any deviations in the approved clinical protocol that may be needed in order to treat the patient:

3)Please describe the process for obtaining prospective informed consent:

4)Please describe your plan for monitoring the patient:

K.Documents to be included with this submission

Consent form (clean or signed by patient)

Investigational brochure

Authorization from the sponsor

Letter of concurrence from an independent physician

IDE supplement to be submitted to FDA from sponsor

L.Acknowledgement

Signature of Principal Investigator Date

Compassionate Use of an Investigational Device Request Form

CF-219, Effective 2-7-2011Page 1