(b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.”? REVIEWER’S COMMENTS (Include here or attach additional sheet): Reviewer’s signature Date APPENDIX 28: EXPEDITED REVIEW WORKSHEET FOR CONTINUING REVIEW New York State Department of Health Institutional Review Board Reviewer’s Expedited/Continuing Review Checklist INVESTIGATOR: Study Title: IMPORTANT ISSUES FOR YOU REVIEW ARE: That the to subjects are still minimized. That the risks to subjects are still reasonable in relation to anticipated benefits. That the number of subjects initially requested and approved has not been exceeded. Any protocol revisions that have been approved by the IRB since the last continuing review. Any request for protocol revision at the time of continuing review. Determine if the study appears to be progressing as planned. If unexpected events, toxicity, or complications have occurred that may indicate a need for a change in the protocol or consent. If the subjects registered any complaints about the study. Whether the consent document that is currently in use contains all previous revisions. Review a current report from the data-monitoring mechanism (Principal Investigator, Data-Monitoring Committee, or Data Safety Monitoring Board) to determine that study events are being evaluated relative to the appropriate stopping or modification rules. (It is appropriate for the IRB to require a
(b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.”? REVIEWER’S COMMENTS (Include here or attach additional sheet): Reviewer’s signature Date APPENDIX 28: EXPEDITED REVIEW WORKSHEET FOR CONTINUING REVIEW New York State Department of Health Institutional Review Board Reviewer’s Expedited/Continuing Review Checklist Study Title: IMPORTANT ISSUES FOR YOU REVIEW ARE: That the to subjects are still minimized. That the risks to subjects are still reasonable in relation to anticipated benefits. That the number of subjects initially requested and approved has not been exceeded. Any protocol revisions that have been approved by the IRB since the last continuing review. Any request for protocol revision at the time of continuing review. Determine if the study appears to be progressing as planned. If unexpected events, toxicity, or complications have occurred that may indicate a need for a change in the protocol or consent. If the subjects registered any complaints about the study. Whether the consent document that is currently in use contains all previous revisions. Review a current report from the data-monitoring mechanism (Principal Investigator, Data-Monitoring Committee, or Data Safety Monitoring Board) to determine that study events are being evaluated relative to the appropriate stopping or modification rules. (It is appropriate for the IRB to require a INVESTIGATOR:
irbguidelines_v_4.docx