ADVENTIST HEALTHCARE INC
Adventist HealthCare Institutional Review Board
Emergency Use Request or Report
IRB Study #: Organizational Entity:
Study Name:
Principal Investigator (PI):
Form Completed by:
|To the extent possible, this form should be submitted to the IRB prior to the use of the investigational drug, biologic, or device. In the event there is not |
|sufficient time to submit this form to the IRB prior to the emergency use of the investigational drug, biologic, or device, it must be submitted to the IRB within |
|5 working days of the use of the investigational drug, biologic, or device. |
|1. Administrative Information |
|A. Select one: Request for Emergency Use (Prospective) Report of Emergency Use (Retrospective) |
|Request for use of (name of drug, biologic, or device): |
|IND/IDE # (if any): |
|B. Name of Sponsor/Manufacturer: | |
|C. Medical Indication: | |
|D. Patient’s Full Name: | |
|Age of Patient: | |
|E. Patient Location: | |
|F. Dates of Treatment: to |
|G. Dose or Description of Treatment: |
|2. Justification for Emergency Use (Check all that apply) |
|Drug or Biologic |Medical Device |
| Immediate life-threatening condition | IDE does not exist for device |
|No standard acceptable treatment is available |IDE exists with non-AHC institution/physician |
|Potential benefit justifies potential risk |IDE exists for another use |
|Drug/biologic not available to patient under an approved protocol |Immediate life-threatening condition |
| |No generally acceptable treatment is available |
|Use will not interfere with ongoing investigations |Insufficient time for FDA approval |
| |Informed consent will be obtained |
|Emergency use approved by FDA |Informed consent will not be obtained |
|Informed consent will be obtained |Independent physician concurs with use |
|Informed consent will not be obtained | |
|Independent physician concurs with use | |
|Describe the Life Threatening Condition: |
|Additional Comments: | |
|3. Investigator’s Assurance |
|I certify that this emergency use will be/was conducted in compliance with the regulatory requirements outlined in the IRB Handbook, including all reporting |
|requirements to the IRB, the FDA and the Sponsor/Manufacturer. |
|SIGNATURE |
| |
|_________________________________________________ _____ |
|Signature of the Principal Investigator Date |
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