eResearch

Overview Core IRB Staff have the ability to "flag" a study with an action item via the Manage Action Items activity in the submission workspace.

Overview Important Information If a document fails to finalize or it should not be stamped, this activity can be used to move documents to the APPROVED section of the Documents Tab. Navigation Home Workspace > Study Workspace

Overview When a submission (application or amendment) is assigned to an MCRU Reviewer, the submission displays in the reviewer’s Inbox tab. The reviewer can then complete the reviewer checklist and submit their review as many times as necessary; however, the first time the review indicates that the submission is approved, the submission moves to the reviewer’s In Progress tab. Once MCRU review is complete, it displays on the reviewer’s Completed tab. Navigation Role: MCRU > Home Workspace

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

Overview A 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) Committee Meeting Workspace Navigation Role: Committee Member 

Overview When 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.

Overview When 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.

Overview Non-Committee Members (Ad-Hoc Reviewers) asked to review an eRRM submission will be notified via email. Reviewers should access eRRM submissions assigned to them via the email link. Navigation Role: 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