eBridge Human Research Enhancements
Posted 3/25/13 - In the March 30, 2013 eBridge Production Patch, several enhancements will be added to the eBridge Human Research Submission Module. Please review each announcement below:
Contents (Select to Jump):
New Button for Closing a Study
The new “Close My Study – Final Report” button is now available on the Study Workspace. Clicking this button will automatically guide study teams through the Final Report SmartForm for closing their study. Previously, the study team would click on Open New CPR and indicate within the CPR SmartForm if the study was to remain open or was to close. With this change, the Open New CPR button guides study teams through the options for keeping the study open only. This change was made for study teams to quickly create a submission for closing their study and lessen confusion on how to open a final report in eBridge.
Change When Approved Stamped Consent Form is Displayed
The Approved Stamped Consent form will now be available in the Study Workspace under the Consents/Docs tab at the same time the Chair sends the Decision Letter. Prior to this change, there was a delay before the stamped consent form could be uploaded into eBridge. Only currently approved consents will display under the Consents/Docs tab. Previously approved versions of Consent are displayed in the Study Workspace, under the Project Information Links section in the new “Archived Consent Forms” section.
Change in When Projects Expire
Projects due to expire will transition to the state of “Expired” in addition to being issued an expiration letter sent close to 12:00 a.m. (midnight) of the expiration date. Currently, protocols are transitioned to the state of “Expired” and issued an expiration letter the morning of the expiration date. This change will align MCW/FH IRB SOPs with activities in eBridge.
Amendment Approval Letters Reflect Amended Project Title
Amendment Approval Letters will now reflect the approved, amended project title that was changed in the Amendment submission. Previously, the Amendment Approval Letters were displaying the unchanged title from the Approved Protocol. This created a challenge for study teams needing to provide an approval letter to their sponsor reflecting the current study title. This change will provide study teams with an accurate approval letter faster and without requiring the need for a second Amendment or a correction letter from the IRB.
Text Change to PRO SmartForm Question 31.1
The text was changed to simplify the question and elicit only one piece of information.
31.1 * Explain which procedures are research-related and which are not:
31.1 * Explain which procedures are research-related: