KUMC Institutional Review Board

Emergency Use Notification

Directions:

1.  download, complete and save this form to your desktop / treatment files.

2.  Please note that this Document and any supporting documents will need to be submitted Five Working Days after the drug is administered.

3.  access the eIRB system at: www.ecompliance.ku.edu

4.  Please complete the requested information in the other application tabs. This will include creating a study title. Please include the term “EMERGENCY USE” in the study title and the DRUG NAME. For example, the title should read “Emergency Use of Drug X.”

5.  Several other documents should be uploaded to the eIRB system. Please upload these documents in the “Supporting Documents” tab.

a.  Please upload a protocol for the use of the product. This can be the treatment plan submitted to the IRB for the initial acknowledgment.

b.  Please upload confirmation of the IND number.

c.  Please email a copy of the patient’s signed consent form to

Principal Investigator:

Department:

Phone:

Today’s Date:

STUDY TITLE:

I.  Emergency Use Information

(a)  Name of Drug/Device used:

(b)  Please confirm that the Pharmacy department at KUMC was used

Yes No

1.  If no, please describe how the drug was administered to the patient:

(c)  Emergency IND # obtained from FDA:

(d)  Please briefly attest to the three required emergency use criteria.

1.  The patient was confronted by a life-threatening or severely debilitating situation necessitating the use of the drug/device. Please elaborate on the situation.

2.  No alternative method of approval or generally recognized therapy was available that provides an equal or greater likelihood of saving the patient’s life. Please describe the lack of therapies or other failed therapies:

3.  There was not sufficient time to obtain IRB approval in advance of the use of the drug/device. Please explain why there was not sufficient time to obtain IRB approval prior to the Emergency use:

(e)  Please describe the current state of the patient:

II.  Future use of the test article

(a)  Please describe any plans to use the drug or device in the future:

If you do plan on using this test article in the future, please submit a new research application to the IRB using the eIRB system allowing for continued and expanded access.

Page 1 of 2 For questions about this form, contact the HSC Office at (913) 588-1240