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U-MIC Site-Specific Protocol Addenda Guidance

This presentation guides on U-M specific protocol modifications for multi-site studies. Understand when UM-specific addenda are needed and the procedures to follow. Access forms, make changes, and get IRBMED approval.

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U-MIC Site-Specific Protocol Addenda Guidance

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  1. 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. Developed by: U-MIC

  2. Site-specific protocol addenda Developed by: U-MIC University of Michigan IRB Collaborative

  3. 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 Site-specific protocol addenda Developed by: U-MIC

  4. 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 Site-specific protocol addenda Developed by: U-MIC

  5. 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 Site-specific protocol addenda Developed by: U-MIC

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

  7. UM-specific protocol addenda are appropriate for only some situations. Site-specific protocol addenda 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. Developed by: U-MIC

  8. UM-specific protocol addenda are appropriate for only some situations. Site-specific protocol addenda 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. Developed by: U-MIC

  9. UM-specific protocol addenda are appropriate for only some situations. Site-specific protocol addenda 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— Developed by: U-MIC

  10. UM-specific protocol addenda are appropriate for only some situations. Site-specific protocol addenda 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. Developed by: U-MIC

  11. UM-specific protocol addenda are appropriate for only some situations. Site-specific protocol addenda 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. Developed by: U-MIC

  12. UM-specific protocol addenda are appropriate for only some situations. Site-specific protocol addenda 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. Developed by: U-MIC

  13. UM-specific protocol addenda are appropriate for only some situations. Site-specific protocol addenda 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. Developed by: U-MIC

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

  15. S. Joseph Austin Judy Birk IRBMED thank you. Developed by: U-MIC

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