Reporting Undesirable SBS Research Events Form The Reporting Undesirable SBS Research Events form form) goes through a series of questions that will help you to determine if you need to submit the form and what information you need to provide the Board. Please refer to the in the section of our website in order to answer the questions accurately. If you have questions about this form and/or reporting an undesirable event, please consult our website or our office. The series of questions should help you to determine if it is the incident to our office. If you determine that you need to submit the form, please submit the form within 7 days of the incident. To submit the document, you can email a scanned version to , fax it to 434-924-2932, or . Our office will review the form and advise regarding your next steps, which may include submitting a modification to your protocol/consent forms. Protocol Information: IRB-SBS Protocol Number: Protocol Title: Principal Investigator: Describe the event: Provide a detailed account of the undesirable event including information about the number of participants involved, what happened, the harm that occurred (if any), how the incident diverged from the protocol, and any steps you may have taken to mitigate the situation. Question Tree Does the event fit the definition of an ? Yes No a; 2. If yes, answer if no, skip to Is the event ? Yes No i; b. If yes, answer if no, skip to Is the ? Yes No ii; d If yes, answer if no, skip to ii. Is the event occurring at a significantly higher frequency and/or severity than previously predicted? Yes No If yes, submit this report. If no, skip to d. Is the ? Yes No c; d. If yes, answer if no, skip to Is the event related or possibly related to the research study? Yes No submit this report; d. If yes, if no, continue to Does the event alter the level of risk to participants? Yes No e. If yes or no, continue to Does the event require you to alter the protocol and/or consent forms? Yes No submit this form. 2. If you answered yes to d and/or e, If you said no to both, continue to Does the event fit the definition of ? Yes No
Reporting Undesirable SBS Research Events Form The Reporting Undesirable SBS Research Events form form) goes through a series of questions that will help you to determine if you need to submit the form and what information you need to provide the Board. Please refer to the in the section of our website in order to answer the questions accurately. If you have questions about this form and/or reporting an undesirable event, please consult our website or our office. The series of questions should help you to determine if it is the incident to our office. If you determine that you need to submit the form, please submit the form within 7 days of the incident. To submit the document, you can email a scanned version to , fax it to 434-924-2932, or . Our office will review the form and advise regarding your next steps, which may include submitting a modification to your protocol/consent forms. Protocol Information: IRB-SBS Protocol Number: Protocol Title: Principal Investigator: Describe the event: Provide a detailed account of the undesirable event including information about the number of participants involved, what happened, the harm that occurred (if any), how the incident diverged from the protocol, and any steps you may have taken to mitigate the situation. Question Tree Does the event fit the definition of an ? Yes No If yes, answer a; if no, skip to 2. Is the event ? Yes No If yes, answer i; if no, skip to b. Is the ? Yes No If yes, answer ii; if no, skip to d ii. Is the event occurring at a significantly higher frequency and/or severity than previously predicted? Yes No If yes, submit this report. If no, skip to d. Is the ? Yes No If yes, answer c; if no, skip to d. Is the event related or possibly related to the research study? Yes No If yes, submit this report; if no, continue to d. Does the event alter the level of risk to participants? Yes No If yes or no, continue to e. Does the event require you to alter the protocol and/or consent forms? Yes No If you answered yes to d and/or e, submit this form. If you said no to both, continue to 2. Does the event fit the definition of ? Yes No