mri-integration | Medical College of Wisconsin

NEW! MRI Integration for PRO and AUA SmartForms in eBridge

The Research MRI Safety Office, IACUC and MCW/FH IRB Offices, and Research Systems are proud to announce a new and innovative approach to obtaining Research MRI Safety Approvals by fully integrating the application and review processes into eBridge, MCW’s Research Management Application. For more information, continue reading or download our startup guide to share with your team.

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What’s Changed?

MRI-related questions will now be placed directly into the AUA and PRO eBridge SmartForms, thereby eliminating the need for a separate MRI Safety application. With this, the MRI Committee review process will also be integrated into eBridge resulting in faster communication of approvals.

Who’s Affected?

All investigative personnel, administrative staff, and reviewers (MCW/FH IRB, IACUC and Research MRI Safety Committee) associated with MRI-related research.

SmartForm & Workflow Changes

PRO CHANGES

Human research projects involving MRI and being reviewed by the MCW/FH IRB, will be required to complete the MRI-related questions located in Section 10B of the PRO SmartForm.
Individuals (including Principal Investigators) who will be entering the magnetic environment will be required to complete MRI Safety training prior to Research MRI Safety Committee approval.
Research MRI Safety Committee approval is required before the PRO SmartForm will be reviewed by the MCW/FH IRB Office.
New MRI-related questions will be required to be completed upon the creation of a new, amended or renewal PRO application.
If human research projects involving MRI will be reviewed by a non-MCW/FH IRB, a separate MRI Safety application will need to be submitted.

AUA CHANGES

Animal studies involving MRI and being reviewed by the MCW IACUC, will be required to complete the MRI-related questions located in Section N of the AUA SmartForm.
Individuals (including Principal Investigators) who will be entering the magnetic environment will be required to complete MRI Safety training prior to Research MRI Safety Committee approval.
Upon submission of the AUA, Research MRI Safety Committee and IACUC review will occur concurrently.
New MRI-related questions will be required to be completed upon the creation of a new, amended or 3 year renewal AUA application.
If animal studies involving MRI will be reviewed by an non-MCW IACUC (VA, MU, UWM), a separate MRI Safety application will need to be submitted.

PRO SmartForm FAQs

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Do I still need approval If my Study being reviewed by a non-MCW-FH IRB?

If your human research project will be reviewed by a non-MCW/FH IRB, a separate MRI Safety application will ALSO need to be submitted.

GO TO MRI FORMS

Is training required for MRI related projects?

Individuals (including Principal Investigators) who will be entering the magnetic environment will be required to complete MRI Safety training prior to Research MRI Safety Committee approval.

FIND OUT MORE

My PRO will be under review at the time of Go Live. What will happen to my submission?

If you have a new PRO under review at the time of Go Live, the new MRI questions will display following Go Live in any PRO with an MRI component. Completion of these questions and subsequent review by the Research MRI Safety Committee will be required prior to IRB approval.

If you have a 6 year renewal under review at the time of Go Live, the new MRI questions will display following Go Live for any PRO with an MRI component. Completion of these questions and subsequent review by the Research MRI Safety Committee will be required prior to IRB approval.

If you have an amendment under review at the time of Go Live, the new MRI questions will display following Go Live in for any PRO with an MRI component. Depending on the nature of the Amendment, completion of these questions and subsequent review by the Research MRI Safety Committee may be required prior to IRB approval.

What should I do if my PRO is in PreSubmission?

If the PRO is not time-sensitive, consider waiting to submit the project until late June 2019, after Go Live. Do NOT submit an MRI Paper Application for any PROs that will be submitted on or after May 28, 2019. The appropriate MRI questions will be incorporated during the IRB review process.

What type of human projects require completion of the new MRI questions?

Human research projects involving MRI and being reviewed by the MCW/FH IRB, will be required to complete the MRI-related questions located in Section 10B of the PRO SmartForm.

What will happen if I create my PRO after Go Live?

The new MRI questions will display in any PRO with an MRI component. Completion of these questions and subsequent review by the Research MRI Safety Committee will be required prior to IRB approval.

When will the MCW-FH IRB Office review the SmartForm?

Research MRI Safety Committee approval is required before the PRO SmartForm will be reviewed by the IRB Office.

When will the Research MRI Safety Committee review the PRO SmartForm?

Research MRI Safety Committee approval is required before the PRO SmartForm will be reviewed by the IRB Office.

Will a PRO 6-year renewal or amendment require the completion of the new MRI-related questions?

New MRI-related questions will be required to be completed upon the creation of a new, amended or renewal PRO application.

Will study personnel involved with MRI procedures need to be listed on the PRO SmartForm?

Any person who will be entering the magnetic environment and/or involved with MRI procedures will need to be listed on the PRO SmartForm.

Will the MRI changes affect the review time for human research projects?

These changes are designed to help streamline the review process for both the Research MRI Safety Committee and MCW/FH IRB.

AUA SmartForm FAQs

Please contact the Research MRI Safety Office at MRIresearch@mcw.edu with additional questions.

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Will the MRI changes affect the review time for animal studies?

These changes are designed to help streamline the review process for both the Research MRI Safety Committee and MCW IACUC.

What type of animal studies require completion of the new MRI questions?

Animal studies involving MRI and being reviewed by the MCW IACUC will be required to complete the MRI-related questions located in Section N of the AUA SmartForm.

Will study personnel involved with MRI procedures need to be listed on the AUA SmartForm?

Any person who will be entering the magnetic environment and/or involved with MRI procedures will need to be listed on the AUA SmartForm, even if they will not be handling live animals.

Is training required for MRI related projects?

Individuals (including Principal Investigators) who will be entering the magnetic environment will be required to complete MRI Safety training prior to Research MRI Safety Committee approval.

Find Out More

When will the Research MRI Safety Committee review the AUA SmartForm? When will the IACUC review the SmartForm?

Upon submission of the AUA, Research MRI Safety Committee and IACUC review will occur concurrently.

Will an AUA 3-year de novo or amendment require the completion of the new MRI-related questions?

New MRI-related questions will be required to be completed upon the creation of a new, amended or 3-year de novo AUA application.

If the animal study is also being reviewed by a non-MCW IACUC (VA, MU, UWM), does the study still require Research MRI Safety approval?

If animal studies involving MRI will be reviewed by an non-MCW IACUC (VA, MU, UWM), a separate MRI Safety application will need to be submitted if the scans are being performed within the MCW/FH network.

GO TO MRI FORMS

My AUA will be under review at the time of Go Live. What will happen to my submission?

If you have a new AUA under review at the time of Go Live, the new MRI questions will display following Go Live in any AUA with an MRI component. Completion of these questions and subsequent review by the Research MRI Safety Committee will be required prior to IACUC approval.

If you have a 3 year renewal under review at the time of Go Live, the new MRI questions will display following Go Live for any AUAs with an MRI component. Completion of these questions and subsequent review by the Research MRI Safety Committee will be required prior to IACUC approval.

If you have an amendment under review at the time of Go Live, the new MRI questions will display following Go Live for any AUA with an MRI component. Completion of these questions and subsequent review by the Research MRI Safety Committee will be required prior to IACUC approval.

What should I do if my AUA is in PreSubmission?

If the AUA is not time-sensitive, consider waiting to submit the application until late June 2019, after Go Live. Do NOT submit an MRI Paper Application for any AUAs that will be submitted on or after May 28, 2019. The appropriate MRI questions will be incorporated during the IACUC review process.

What will happen if I create my AUA after Go Live?

The new MRI questions will display in any AUA with an MRI component. Completion of these questions and subsequent review by the Research MRI Safety Committee will be required prior to IACUC approval.