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GENERAL INFORMationTreating Physician Name:Department:Date of Follow-Up Report: FORMTEXT        FORMTEXT       FORMTEXT      Name of Test Article:Patient Initials:Date of Treatment: FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  Patient outcomesDescribe the outcome of the emergency use to date:  FORMTEXT       If a waiver of consent was originally applied, has the patient and/or the patient s legally authorized representative been notified of the use of the test article and consent to continue use obtained?  FORMCHECKBOX  YES  FORMCHECKBOX  NO If Yes, attach a copy of the signed consent document. FORMCHECKBOX  SERIOUS ADVERSE EVENT (SAE)Note: Only events that are SERIOUS, UNEXPECTED and RELATED to the administration of the test article need to be reported to the RSRB.SAE Onset Date:  FORMTEXT      SAE Description & Treatment:  FORMTEXT      Seriousness (check all that apply):  FORMCHECKBOX  Fatal FORMCHECKBOX  Life Threatening FORMCHECKBOX  Permanent Disability FORMCHECKBOX  Hospitalization  FORMCHECKBOX  Congenital Anomaly/Birth Defect  FORMCHECKBOX  Other (specify):  FORMTEXT       FORMCHECKBOX  Saving Intervention RequiredRelationship to Test Article: FORMCHECKBOX  Possibly/Probably FORMCHECKBOX  Definitely RelatedExpectednes&'(6NR^_mopϿ|paUaFa|:hEFCJOJQJaJhCnh7 2CJOJQJaJh^XCJOJQJaJhCnh@CJOJQJaJhuiCJOJQJaJhCnh|CJOJQJaJ"hCnh|5>*CJOJQJaJhCnhV7CJOJQJaJ%hCnh4>B*CJOJQJaJphhCnh}O5CJOJQJaJhCnh=5CJOJQJaJhCnh@5CJOJQJaJhCnhCn5CJOJQJaJ'(6  XO $IfgdnRxkd$$Ifl&& @ t 0&44 lalp ytEF $IfgdF$ & F^`gd| & Fgd^Xgd|;$a$gd=   * P Q        ɺɢ}l]N>hCnh`>*CJOJQJaJhaDh 1CJOJQJaJhaDh 10JCJOJQJ!jh 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