CHECKLIST: Minutes Quality Improvement Assessment

AUDIT TOOL CHECKLIST: Quality Assurance Assessment

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HRP-432 7/1/2015 1 of 2

The purpose of this checklist is to allow individuals to conduct a quality assessment of IRB submissions. IRB Number Meeting or Determination Date Name of Person Completing Worksheet Date Worksheet Completed 1 Pre-Review Requirements Yes No If changes were requested at pre-review, were reasons/rationale provided for each change in N/A the message to the investigator? Yes No Was the appropriate regulatory oversight selected? Yes No Was the appropriate risk level selected? Yes No Was the appropriate type of research selected? Yes No Were the correct special determinations selected and communicated to the reviewer/Board? Yes No Were any missing materials clearly documented and received prior to IRB review approval? N/A (N/A if there were no missing materials at the time of pre-review.) Yes No Were all required ancillary reviews completed? (N/A if there were no ancillary reviews N/A required) Yes No Were all CITI or other training requirements completed for research staff? Describe results of follow-up discussions on any items checked “No”: Requirements for Each Submission Reviewed Yes No Did the reviewer have a conflicting interest with the submission? Yes No For Non-Committee Review, do you agree with the selected review level and categories? (N/A N/A if submission was not classified as a Non-Committee Review.) Yes No Did Modifications Required to Secure Approval, Deferral or Disapproval correspondence to N/A investigator indicate reason/rationale for required changes? (N/A if IRB determination was not Modifications Required to Secure Approval, Deferral or Disapproval.) Yes No Were required checklists uploaded? (N/A if no checklists were required.) N/A Yes No Were all final contingencies identified during pre-review addressed during the review? (N/A if N/A no final contingencies were identified.) Yes No If checklists were required, were they complete? (N/A if no checklists were required.) N/A Yes No If checklists were required, was the appropriate justification supplied for each question? (N/A N/A if no checklists were required.) AUDIT TOOL CHECKLIST: Quality Assurance Assessment

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HRP-432 7/1/2015 2 of 2

Yes No Was the review completed in a timely manner, e.g., within 10 business days for IRB staff Designated Review or 15 business days for non-IRB staff Designated Review? Yes No Was the correct approval date indicated? Yes No Was the correct effective date indicated? N/A Yes No Was the correct last day of approval period indicated? Describe results of follow-up discussions on any items checked “No”: Post-Review Requirements Yes No Is the information in the approved minutes consistent with the documentation in investigator N/A correspondence? (N/A for non-committee review) Yes No Were the appropriate documents finalized with the correct approval and last day of approval period? Yes No Was the letter correctly prepared, including all necessary information? Yes No Was the letter sent within 5 days of determination or meeting? Yes No If Full Committee, was the letter sent within 10 days after the minutes were approved? N/A Describe results of follow-up discussions on any items checked “No”: