eResearch

Overview When applications or amendments requiring review by MCRU are received, they display on the Inbox tab in the MCRU Staff Workspace. MCRU Staff are responsible for assigning the submission to the appropriate reviewers. Once reviews are submitted by the Financial, Clinical and Lab Reviewers, MCRU Staff can generate and print the MCRU Meeting Report and, after holding the feasibility meeting, execute the Complete MCRU Review activity. Navigation Role: MCRU > Home Workspace

OverviewA Committee Member can confirm or deny their meeting attendance in one of three ways:Email Notification (from either a Special Notice email or a Meeting Agenda email)CommitteeMeeting WorkspaceNavigationRole: Committee Member 

OverviewWhen a new study application or amendment requiring MIAP review is submitted, it automatically displays in the MIAP Reviewer’s Home workspace. If a study does not meet the criteria to trigger automatic MIAP review, applicable Ancillary Committees, IRBs and MIAP can manually assign a submission for MIAP review using the Update MIAP Review Requirements activity in the applicable submission workspace.

Overview A study team member can use the Move to Ready to Submit Inbox activity to alert selected team members that the study application (or amendment) is ready to submit. This activity moves the application or amendment into the Ready to Submit section of the Principal Investigator's Inbox (and/or anyone else with access to submit) and sends an email notification.   Note Competing this activity is optional.

OverviewWhen you log in to eResearch Regulatory Management (eRRM), your My Home page (i.e. Home Workspace) displays. You can initiate a variety of activities, access other applications (i.e. workspaces), and view any items that require your attention.

OverviewNon-Committee Members (Ad-Hoc Reviewers) asked to review an eResearch Regulatory Management (eRRM) submission will be notified via email. Reviewers should access eRRM submissions assigned to them via the email link.NavigationRole: Ad-Hoc Reviewer > eRRM Ad-Hoc Reviewer email notification

Overview Core Committee Staff can use the Notify Participating Sites PI activity from the Multi-Site (parent) Study workspace to send an email to the local Site PI(s), notifying them that they can commence work on their University of Michigan Participating Site Application. Navigation Role: Core Committee Staff > My Home > Study workspace

Overview When you select a Participating Site from your My Home page, the Participating Site workspace displays. In some cases, you may receive an email notification that a participating site application has been assigned to you, with a direct link to the workspace. Navigation Role: PI/Study Team Member or Core Committee Staff > Participating Site workspace

OverviewThis document provides an overview of the IBC Application and the functionality within it.The IBC Application has these high-level sections:

Overview Study Team Members (U-M and sponsored affiliates) and Core Committee Staff can use the Post Correspondence activity to communicate with others involved with the study. Post Correspondence is a communication tool only and will not update or submit your application.