Overview
Newly submitted Repository Applications display on the Unassigned tab of the IRB Staff Home Workspace. IRB Staff complete an initial review of newly submitted Repository Applications, including requesting any required changes to the application from the Repository Director, before the application is routed for IRB Committee review.
eResearch
Overview
Newly submitted Participating Site Applications display on the Unassigned tab of the Core Committee Staff Home Workspace. IRB Staff complete an initial review of newly submitted Site applications, including requesting any required changes to the site application from the Site PI, before the application is routed for IRB Committee Review.
Overview
To access eResearch Regulatory Management (eRRM), navigate to the eResearch website. You will need a uniqname or Sponsored affiliate account (or a Friend account) and UMICH password to log in.
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.