- How do I access information from a withdrawn amendment?
1. Locate and open the project. From the “Study Workspace”, select the “Amendments” tab. All amendments for the study are located under this tab. Select the withdrawn amendment. From the “Amendment Workspace”, and from the left column, select the “Printer-Friendly Version” button below the “View Amendment” button to copy and paste desired information into the new Amendment SmartForm.
2. Likewise, information from the modified study of the withdrawn amendment can be copied and pasted into the modified study of the new amendment by selecting the “Print-Friendly Study” button below “View Study History.”
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- When can I use the SmartForm Update activity?
You can use the SmartForm Update activity to make the changes listed below to protocols in the “Approved” state without creating an amendment as long as an amendment is not open. The Principal Investigator and study staff listed on the approved protocol are able to execute this activity.
Changes that can be made to an approved Protocol without IRB review & Committee approval are:
• Protocol, Section 1.6 – phone/pager number for after hours communication
• Protocol, Section 2.1 – individuals who can edit the SmartForm
• Protocol, Section 2.2 – individuals who can receive email notification about this protocol Return to Top
- Why does the Principal Investigator have to submit the study, CPR, Amendment or Reportable Event?
The Principal Investigator has to initially submit the application because the PI needs to attest to its accuracy and because the PI is personally responsible for the study and all related activities. Return to Top
- How do I link an IRB Protocol to a Budget?
Instructions for linking an IRB Protocol to a budget can be found at the link below.
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- How do I change the PI on a PRO?
If the PI is no longer employed at MCW, have a Study Staff who is listed on the PRO with edit rights, navigate to the PRO. Open an AME. Complete the AME SmartForm. Then navigate by using the View/Edit Modified Study in the AME Workspace. Change the PI in Question 1.3, Save and Exit. The new PI will now have the activity to Submit the AME.
Once the AME is Approved, eBridge is triggered to change the PI in the PRO. During the Approval process the new PI will not be able to edit the study or do anything else. Return to Top
- Why can only one Amendment be opened at a time?
When an Amendment is created in the eBridge system, the system makes a copy of the currently approved study, so two copies of the same study are in the system. The second copy is open for your modification as part of completing the amendment process. Once approved by the committee, the modified study replaces the previously approved study. This way the study always incorporates all the approved changes through all of the amendments. If you were able to open a second amendment at the same time as the first, there would now be three copies of the same study. This would be like two people editing the same Word document at the same time. It is difficult to impossible to resolve the differences between the two modified copies of the study. Return to Top
- Why does the Department have to review new studies?
The Department has to review new studies because the Department has to attest that the faculty member submitting this research protocol is in good standing in the department, that the department is aware of the research protocol, and the department is willing to commit the resources necessary for conducting this research protocol. Return to Top
- How do I close a study in eBridge?
To close a human submission study in eBridge, from the Study Workspace and from the left column, select the "Close My Study - Final Report" activity, and complete the CPR SmartForm for IRB review and approval.
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