enter Sitespecific protocol addenda Developed by UMIC University of Michigan IRB Collaborative Sitespecific protocol addenda 3 Developed by UMIC Multisite study IRBMED may permit UM participation only with sitespecific protocol ID: 806120
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Slide1
1
Developed by:U-MIC
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Slide2Site-specific protocol addenda
Developed by:
U-MICUniversity of Michigan IRB Collaborative
Slide3Site-specific protocol addenda
3
Developed by:U-MICMulti-site studyIRBMED 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
e
xpedited review
c
onvened Board review
*
protocol:
research project as a whole, including supporting materials
Slide4Site-specific protocol addenda
4
Developed by:U-MICU-M Addendum proceduresIRBMED determines that protocol requires UM-specific modifications.
Study
teamcommunicates UM-specific modifications to sponsor
obtains
U-M Addendum form
uploads completed U-M Addendum document in section 5
i
ndicates in section 1.8 that project is subject to U-M Addendum
Slide5Site-specific protocol addenda
5
Developed by:U-MICU-M Addendum procedures (continued)
IRBMED instructs study team to make all necessary changes to application.
eResearch Cross-Reference TableIRBMED reviews
U-M Addendumapplication
s
upporting materials
Slide6Site-specific protocol addenda
6
Developed by:U-MICUM-specific protocol addenda are appropriate for only some situations.
Appropriate
The protocol for a multi-site study includes minor subjects ages 16 and 17.
Slide7Site-specific protocol addenda
7
Developed by:U-MICUM-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.
Slide8Site-specific protocol addenda
8
Developed by:U-MICUM-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.
Slide9Site-specific protocol addenda
9
Developed by:U-MICUM-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—
Slide10Site-specific protocol addenda
10
Developed by:U-MICUM-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
.
Slide11Site-specific protocol addenda
11
Developed by:U-MICUM-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.
Slide12Site-specific protocol addenda
12
Developed by:U-MICUM-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.
Slide13Site-specific protocol addenda
13
Developed by:U-MICUM-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.
Slide1414
Developed by:
U-MICSite-specific protocol addenda
Site-specific protocol addenda
Slide15thank you.
S. Joseph Austin
Judy BirkIRBMED15Developed by:U-MIC