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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