2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. SITE-SPECIFIC PROTOCOL ADDENDA Developed by: U-MIC University of Michigan IRB Collaborative

4. Site-specific protocol addenda 3 Developed by: U-MIC Multi-site study IRBMED may permit U-M participation only with site-specific protocol* modifications. Study team submits U-M Addendum. captures all modifications or limitations imposed by IRBMED may be used for studies undergoing expedited review convened Board review * protocol: research project as a whole, including supporting materials

5. Site-specific protocol addenda 4 Developed by: U-MIC U-M Addendum procedures IRBMED determines that protocol requires UM- specific modifications. Study team communicates UM-specific modifications to sponsor obtains U-M Addendum form uploads completed U-M Addendum document in section 5 indicates in section 1.8 that project is subject to U-M Addendum

6. Site-specific protocol addenda 5 Developed by: U-MIC U-M Addendum procedures (continued) IRBMED instructs study team to make all necessary changes to application. eResearch Cross-Reference Table IRBMED reviews U-M Addendum application supporting materials

7. Site-specific protocol addenda 6 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Appropriate The protocol for a multi-site study includes minor subjects ages 16 and 17.

8. Site-specific protocol addenda 7 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Appropriate The protocol for a multi-site study includes minor subjects ages 16 and 17. IRBMED determines that the researcher may not enroll minors at U-M.

9. Site-specific protocol addenda 8 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Appropriate The protocol for a multi-site study includes minor subjects ages 16 and 17. IRBMED determines that the researcher may not enroll minors at U-M. The sponsor will allow U-M to exclude minor subjects but will not permit modifications to the multi-site protocol document.

10. Site-specific protocol addenda 9 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Appropriate The protocol for a multi-site study includes minor subjects ages 16 and 17. IRBMED determines that the researcher may not enroll minors at U-M. The sponsor will allow U-M to exclude minor subjects but will not permit modifications to the multi-site protocol document. Therefore, the study team must complete the U-M Addendum document and make changes to the application and supporting documents—

11. Site-specific protocol addenda 10 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Appropriate The protocol for a multi-site study includes minor subjects ages 16 and 17. IRBMED determines that the researcher may not enroll minors at U-M. The sponsor will allow U-M to exclude minor subjects but will not permit modifications to the multi-site protocol document. Therefore, the study team must complete the U-M Addendum document and make changes to the application and supporting documents—such as deselecting minors as a subject population in Section 9 of the eResearch application and removing references to minor subjects from the consent documents.

12. Site-specific protocol addenda 11 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Inappropriate The protocol for a multi-site study allows for the use of either Multi Gated Acquisition (or MUGA) Scan or echocardiogram for evaluation of heart function for safety monitoring.

13. Site-specific protocol addenda 12 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Inappropriate The protocol for a multi-site study allows for the use of either Multi Gated Acquisition (or MUGA) Scan or echocardiogram for evaluation of heart function for safety monitoring. The investigator at U-M indicates that all subjects at this site will undergo only echocardiogram monitoring.

14. Site-specific protocol addenda 13 Developed by: U-MIC UM-specific protocol addenda are appropriate for only some situations. Inappropriate The protocol for a multi-site study allows for the use of either Multi Gated Acquisition (or MUGA) Scan or echocardiogram for evaluation of heart function for safety monitoring. The investigator at U-M indicates that all subjects at this site will undergo only echocardiogram monitoring. Since the protocol allows for either method, the decision to use echocardiogram only does not require a U-M Addendum.

15. 14 Developed by: U-MIC Site-specific protocol addenda

16. THANK YOU. S. Joseph Austin Judy Birk IRBMED 15 Developed by: U-MIC