Regulatory Management

Filtering allows you to narrow the list of choices and results in many areas of eResearch. For example, if you are looking for a particular study in your Home Workspace, you can filter the list of studies to make it easier to locate that study. In an application, you can filter many different values, such as First name, Last name, ID, Organization, and more. To filter, use % as a wildcard.
Overview Except for those with the role of Principal Investigator or Administrative Staff, study team members who are not affiliated with U-M (i.e., individuals with an eResearch Friend account) must access eResearch Regulatory Management and accept their role before an application can be submitted. This process allows the individual to verify and accept their role on the study team and to maintain compliance with U-M Conflict of Interest policies.
Overview In most instances, when uploading/attaching a file in a section of the Human Subjects Research application (HUM), you have the ability to upload revised versions of the file as needed. If you’ve uploaded multiple versions of a file and wish to revert back to a previously uploaded version, you can do so using the History & Rollback function. Navigation Role: All Roles > Home Workspace > HUM Application > Document location
Overview A roll back is when an eResearch Human Subjects submission is manually moved to a different state in the review process.
Overview This reference document provides the basic steps for common tasks you may take with an IBC Application including:
Overview Participating Site Applications assigned to an IRB Committee member for review display under Participating Sites to Review on the Inbox tab of the Home Workspace. Navigation Role: Committee Member > Home Workspace
Overview Repository Applications assigned to an IRB Committee member for review display under Repository Applications to Review on the Inbox tab of the Home Workspace. Navigation Role: Core Committee Member > Home Workspace
Overview Human Subject Research Application (HUM) Reviews assigned to Full Committee display in the My Reviews list on the Inbox tab of your Home Workspace. Reviewers may view the submitted application, edit the reviewer checklist and submit the review. Navigation Role: Committee Member > Home Workspace
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.
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.