IRB 7.2 IRB Member Training

1. IRB 7.2 IRB Member Training Presented by:Joey Casanova, CIPAssociate Director for Educational InitiativesHuman Subject Research Office

2. Locating Checklists • Several worksheets and checklists are provided in the system to guide your review process and document your decisions. • Worksheets are for the reviewer's benefit only. • Checklists must be completed and attached when submitting your review comments to document your decisions. • To locate the worksheets and checklists: • Click IRB then IRB library in upper left corner. • Click the Worksheets or Checklists tab. • Click a link to open or save the document.

3. IRB 7 Navigation

4. “My Inbox”

5. Understanding Your Inbox

6. The Study Workspace

7. IRB Meeting Agendas

8. Locating Meeting Agenda Items • As a committee member, you can get a meeting agenda listing the studies and other submissions to be reviewed in an upcoming meeting. You can get the agenda in two forms: • As a web page with links to the studies • As a printable document

9. Accessing Agenda from e-mail • To access the meeting workspace web page containing links to the studies, click the link next to Link. • To open or save the printable document, click the link next to Description. • Note: The most up-to-date agenda is in the web page format.

10. Navigating to the Agenda • Click IRB and then IRB Meetings in the upper left corner. • Click the name of the meeting to view. • The meeting workspace displays the list of agenda items in the center of the page.

11. IRB Committee Meeting Agenda

12. Checklists and Worksheets

13. Locating Checklists • Several worksheets and checklists are provided in the system to guide your review process and document your decisions. • Worksheets are for the reviewer's benefit only. • Checklists must be completed and attached when submitting your review comments to document your decisions. • To locate the worksheets and checklists: • Click IRB then IRB library in upper left corner. • Click the Worksheets or Checklists tab. • Click a link to open or save the document.

14. Key Checklists and Worksheets

15. Key Checklists and Worksheets

16. Key Checklists and Worksheets

17. The New Study Application

18. Title as listed in protocol Abbreviated title for easy identification Summary of study Select PI from a list of IRB7 users Disclosures should be consistent with disclosures in DPS Unless prior permission is granted, answer should be “No” Sponsor’s protocol should be uploaded here. For investigator-initiated research, use the protocol templateto develop protocol

19. A list of known funding sources/sponsors will be available. Contact the HSRO if a new source needs to be added.Upload grant application or draft CTA as appropriate Standard study teams may be associated with a PI. Please review to ensure that the study team members listed hereare accurate

20. Answer “yes” only if the UM PI is responsible for the conduct of this study at external sites Used for branching Used for branching

21. List drugs, combinations, etc., to be studiedInvestigator Brochures should be included here as well Check yes if appropriate List as appropriate Upload IND letter or other correspondence from the FDA *This page will only appear if “yes” is selected in question 2 on the Study Scope page

22. List devices to be studiedAny documentation, instructions, etc. associated with the use of the device would be uploaded here as well Check appropriate radio button List as appropriate Upload IDE letter or other correspondence from the FDA *This page will only appear if “yes” is selected in question 3 on the Study Scope page

23. Upload ICF and other documents to be used during consent process Upload advertisements, flyers, patient letters and other documents to be used for recruitment

24. Upload any other documents not already included NOTE: Clicking “Finish” does not submit the study.The PI must log in and click on the submit studylink. NOTE: Only the PI may submit the study.

25. The Modification/ Continuing Review Form

26. Select type of submission NOTE: This question will not appear if “Continuing Review” is selected above

27. Numbers reported here must be consistent withprior reports and, if applicable, Velos Indicate current state of the study

28. If a COI was disclosed at initial submission, or there are no COIs, select “No” Select all that apply Examples: enrollment summaries, summaries of AEs not requiring immediate reporting, summaries of deviations not requiring immediate reporting, DSMB reports, grant progress reports, sponsor letters re: enrollment, etc.

29. Indicate current state of study Indicate whether PI intends to notify subjects List any changes that are UM-specific Study-wide modifications that are described in a sponsor’s amendment do not need to be included here. Study teams may simply state “Refer to sponsor’s summary of changes (or other appropriate document)”

30. NOTE: Clicking “Finish” does not submit the continuing review/modification. The PI must log in and click on the submit link. NOTE: Only the PI may submit the continuing review/modification.

31. The Reportable New Information Form

32. When viewing items in your Inbox or on the IRB Workspace, RNI Short Title will show up underthe “Name” column List date study team became aware of the RNI RNI includes unanticipated problems, newly identified risks, adverse events (unexpected and probably related), deviations and violations, audit or monitoring results, etc. RNIs do not include expected or unrelated AEs, IND Safety Reports, Translations, Sponsor Letters without impact on risks, etc.

33. Summary of RNI

34. Select Yes or No based on PI’s review of the RNI You will be able to list as many studies as are affected. (E.g. PI is involved in multiple studies involving the same drug.) Upload documents as appropriate

35. Completing your Review

36. To complete a designated (or non-committee) review: • Click Submit Designated Review • If true, check the box to indicate that you do not have a conflicting interest • Answer the relevant questions, paying special attention to each required question marked with a red asterisk (*). • (Optional) Add comments and attach documents related to the review

37. To complete a committee review: • Click Submit Committee Review • Answer the relevant questions, paying special attention to each required question marked with a red asterisk (*). • (Optional) Add notes and attach documents related to the committee's review. • Click OK.

38. Thank You! Joey Casanova, CIPAssociate Director for Educational Initiativesjcasanova@med.miami.edu 305-243-9232