Notification of Emergency Use of Investigational Drug, Biologic or Device (Subsequent to Administration of the Test Article)
Office of Research Division of Research Integrity and Compliance
For IRB Staff only: IRB Tracking #:_________
Biomedical Institutional Review Board
OHRP Federalwide Assurance: FWA00001669
FOR INSTRUCTIONS AND A SUBMISSION CHECKLIST FOR THIS FORM, GO TO:
http://www.research.usf.edu/cs/irb_forms/emergency_subsequent_instruct.doc SECTION 1 – DEMOGRAPHIC INFORMATION PRINCIPAL INVESTIGATOR RESPONSES Please make sure all cells contain a response. Cells will expand to allow additional IRB QUESTIONS space for responses. Principal Investigator Information 1 Physician Notifying the IRB of Emergency Use [ ] Resident [ ] Fellow [ ] Faculty 2 Indicate status 3 USF Employee Number
(If not associated with USF, please provide an alpha numeric code consisting of the first 3 letters of your last name & the month and day of your birthdate [abcmmdd]).
USF Department/College or other institution affiliation 5 Mailing Address (where you prefer to receive IRB correspondence) 6 E-mail Address Telephone Number: [Please specify] 7 Telephone and Fax Numbers Contact Person (Person designated to serve as primary contact for all IRB communications). 8 Name and Degree(s) 9 Primary Role 10 Mailing Address (where you prefer to receive IRB correspondence) 11 E-mail Address
Notification of Emergency Use of a Test Article (Subsequent to Administration of the Test Article) Version: 2008-12-10
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Fax Number: [Please specify]
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12 Telephone and Fax Numbers Investigational Article Information 13 Name of Investigational Drug or Biologic: 14 IND #: OR 15 Name of Investigational Device: 16 IDE #: 17 Has there been a previous Emergency Use of this test article at this site? (Please note: FDA regulations only permit one emergency use of a test article at an institution.) 18 Please describe/ explain the test article that was administered. 19 When was the test article administered? 20 How was the test article administered? 21 Please describe the patient’s current condition. 22 Please justify why you believed that there was no alternative method of approved or generally recognized therapy available that provided an equal or greater likelihood of saving the subject's life. 23 Please explain why you believed there was not enough time to obtain IRB review and approval prior to administration of the test article. 24 Please describe how informed consent was obtained (include a description of the consent process, who gave informed consent, e.g., the subject or a legally authorized representative).
Telephone Number: [Please specify]
Fax Number: [Please specify]
[ ] Yes. Explain why this article has been administered in a manner inconsistent with FDA regulations and USF IRB policy.
[ ] No. Explain how you have verified this information:
[ ] Yes
[ ] No
Attach a copy of the signed informed consent document used.
Independent Assessment by an Uninvolved Physician:
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I concur with the following:
the patient who received this test article was in a life-threatening condition; the use of this test article for this patient is/was appropriate; and there is no generally acceptable alternative available for treating the patient.
____________________________________________ Signature of Independent Physician* ____________________________________________ Printed Name of Independent Physician * PLEASE NOTE:
___________________ Date
If you submitted the Notification of Pending Emergency Use Report with the signature of the independent physician, there is no need for the physician to again sign.
Notification of Emergency Use of a Test Article (Subsequent to Administration of the Test Article) Version: 2008-12-10
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Principal Investigator Statement of Assurance
I confirm that this notification of use of an investigational drug, device or biologic meets the Food and Drug Administration criteria for Emergency Use. I also confirm the accuracy of this report. I understand that any subsequent use of this test article at this Institution must first be reviewed and approved by the full IRB at a convened meeting. I understand that it is my responsibility to submit any scientifically significant data regarding this test article to the Food and Drug Administration. I agree to notify the IRB of the outcome of the administration of the test article including the individual’s condition with any follow-up information requested by the IRB.
__________________________________________________ Signature of Physician Who Administered Test Article ___________________________________________________ Printed Name of Physician Who Administered Test Article
__________________________________ Date
IRB staff use only [ ] This use of this test article meets federal criteria for emergency use of a test article. [ ] This use of this test article does not meet the federal criteria for emergency use of a test article. __________________________________________ Signature of IRB Chair or Designee ___________________ Date
Notification of Emergency Use of a Test Article (Subsequent to Administration of the Test Article) Version: 2008-12-10
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