Investigator removed subject from study Subject voluntarily withdrew Investigator removed subject from study 16. Please explain why any subjects were excluded on the basis of race, ethnic group, understanding of English, socioeconomic status, education, gender, or pregnancy: Section 5 Final Report on Research Risks/Benefits-Provide a thorough – response or mark N/A as applicable 17. If there has been any other relevant information regarding this research, especially information about risks associated with the research since the last IRB review please provide a summary of this information: If this information was not reviewed by the IRB please provide the reason: 18. If there have been any relevant study-wide or multi-center trial reports since the last IRB review not previously reviewed by the IRB please summarize and submit a copy: 19. If there have been any data and safety monitoring board reports not submitted to the IRB since the last IRB review please summarize and submit a copy: 20. If the profile of adverse events has changed in terms of frequency, severity, or specificity since the last IRB review and the IRB has not reviewed the changes please summarize the changes and submit any relevant documentation: 21. If all serious or unexpected adverse events have not been reported up to date as required please provide an explanation: 22. If there have been any unanticipated problems involving risks to participants or others since the last IRB review that have not been reviewed by the IRB please summarize and submit the Unanticipated Event Form: 23. If there have been any complaints about the research by any participants or others since the last IRB review that were not reported to Research Compliance Officer and the IRB provide a summary describing the number and nature of the complaints:
Investigator removed subject from study Subject voluntarily withdrew Investigator removed subject from study 16. Please explain why any subjects were excluded on the basis of race, ethnic group, understanding of English, socioeconomic status, education, gender, or pregnancy: Section 5 – Final Report on Research Risks/Benefits-Provide a thorough response or mark N/A as applicable 17. If there has been any other relevant information regarding this research, especially information about risks associated with the research since the last IRB review please provide a summary of this information: If this information was not reviewed by the IRB please provide the reason: 18. If there have been any relevant study-wide or multi-center trial reports since the last IRB review not previously reviewed by the IRB please summarize and submit a copy: 19. If there have been any data and safety monitoring board reports not submitted to the IRB since the last IRB review please summarize and submit a copy: 20. If the profile of adverse events has changed in terms of frequency, severity, or specificity since the last IRB review and the IRB has not reviewed the changes please summarize the changes and submit any relevant documentation: 21. If all serious or unexpected adverse events have not been reported up to date as required please provide an explanation: 22. If there have been any unanticipated problems involving risks to participants or others since the last IRB review that have not been reviewed by the IRB please summarize and submit the Unanticipated Event Form: 23. If there have been any complaints about the research by any participants or others since the last IRB review that were not reported to Research Compliance Officer and the IRB provide a summary describing the number and nature of the complaints:
Study_Closure_Report.2011.docx