AMITA Health
EMERGENCY USE REPORT
(MUST BE TYPEWRITTEN)
Date of Emergency Use:
Name of Treating Physician:
Nature of the test article administered (e.g., investigational drug, biologic or device):
Attach copy of the protocol, or give IRB # if applicable ______
This procedure qualifies as an emergency use due to (check all that apply):
A life-threatening condition that needs immediate treatment.
No generally acceptable alternative treatment for the condition exists.
Because of the immediate need to use the device, there is no time to use existing procedures for FDA approval.
Patient Demographics and Description of Conditions Constituting an Emergency (attach additional sheets if necessary):
Clinical Results of the Emergency Use:
Attach a copy of the informed consent used (if no informed consent obtained, complete page 2)
Treating Physician Signature Date Report Filed with IRB
AMITA Health
EMERGENCY USE REPORT
(MUST BE TYPEWRITTEN)
To be completed if informed consent was not obtained:
I/we certify the following four conditions were met prior to administration of the test article:
1. The patient was confronted by a life-threatening situation (as defined in FDA regulations and outlined in AMITA Health IRB policy, “Emergency Use of a Test Article”) necessitating the use of this product.
2. Informed consent could not be obtained because of an inability to communicate with, or obtain legally effective consent, from the patient.
3. Time was not sufficient to obtain consent from the patient’s legally authorized representative.
4. No alternative method of approved or generally accepted therapy was available that would have provided an equal or greater likelihood of saving the patient’s life.
5. The consulting / reviewing physician is independent both with respect to the treatment of the patient and the clinical investigation of the test article.
Signature of Treating Physician Date of Determination
Name of Consulting or Reviewing Physician
_
Signature of Consulting or Reviewing Physician Date of Determination / Review
1
Emergency Use Report
Version: 1 May 2008, rev 10-30-08, 8-7-12, 9-21-15