ࡱ> QSP] 1bjbj 08!b!b K4 4 8LH,0.t^^^^9h< ///////$140]990^^y0!!!F^^/!/!!r+T,^@cCRb+/000p+55,,5",!00054 B v: Adverse Event/Unanticipated Problem Report Use the form below to promptly report an adverse event/unanticipated problem to the SWAGƵIRB. The principal investigator (PI) is responsible to respond to the adverse event/unanticipated problem immediately, providing care in accordance with the IRB approved protocol. The PI must provide his/her opinion as to the necessity for proposed changes to the protocol and/or consent form. If an adverse event that is both serious and unanticipated occurs, the PI must notify the IRB within 24 hours. In case of an adverse event that is serious but not unanticipated, the PI must notify the IRB within 5 working days. In case of an adverse event that is not serious, but is unanticipated, the PI must notify the IRB within 10 working days. If an unanticipated event involving risks to subjects or others (but not meeting the definition of an adverse event) occurs, the PI must notify the IRB within 10 working days. Note: if a sponsor funds or supports the study, then the principal investigator is responsible for notifying the sponsor of any adverse events. Project Title:  FORMTEXT       PI Name:  FORMTEXT       Department:  FORMTEXT       Phone/Email:  FORMTEXT       Submission date of this report:  FORMTEXT       Funding agency (if applicable):  FORMTEXT       Adverse event/unanticipated problem questionnaire: please provide a response to each question Is it possible that the adverse event/unanticipated problem and study procedures are related?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Is the event being reported serious and unexpected (i.e., the risk was not included in current protocol or consent documents)?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Did this event occur to a subject enrolled in your study?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Was the event attributable to a study procedure?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Has this type of event been reported before in this or other studies?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Is this type of event likely to occur again?  FORMCHECKBOX  Yes  FORMCHECKBOX  No In your judgment, is a change in the procedure necessary to reduce or eliminate harm or risk to subjects?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Will the event require changes in the consent form to adequately inform subjects?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Will currently enrolled subjects be notified of this event?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Note: If yes is checked to either question number 7 and/or 8, please submit an amendment request to the IRB Coordinator. Adverse event/unanticipated problem details: please provide a response to each question Subject information Subjects Name:  FORMTEXT       Subject s Age:  FORMTEXT       Event Information Date of event/occurrence:  FORMTEXT       Location of event:  FORMTEXT       Time of event:  FORMTEXT       Provide a description of the adverse event/unanticipated probl*+,BJK< @ U  C f l  < V ǿǿǴǴϨϿϿڠwshZhM^hM^5hM^hZCJaJh ^h ^CJaJh ^hZCJaJhqhCJaJhqhhqhCJ\aJh ^h CJaJhdCJaJh CJaJhqhhqhCJaJhqhhqh5CJaJhqhhZCJaJhHfm hm$5 hZ5,+, , . 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FORMTEXT       Have you sought or received any follow up information from the subject? If so, please describD-F-00002040D1F1H1J1L1P1R1V1X1\1^1b1d1r1t1v1  !`'gdvXgdOJgd5|$a$gdEgd&gds & Fgdsgdse.  FORMTEXT       Please contact the IRB Coordinator (540-232-8425) or  HYPERLINK "mailto:irb@vcom.vt.edu" irb@vcom.vt.edu if you have any questions.     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