eResearch

Regulatory Management: IBC Application Workspace & Common Tasks

OverviewThis document provides the basic steps for common tasks you may take with an IBC Application including:Find your IBC ApplicationIBC Application Workspace FeaturesView your IBC ApplicationAmend or Renew your Approved IBC ApplicationFind your Amendments or RenewalsNavigationRole: Study Team Member > Home Workspace > IBC Application Workspace

Regulatory Management: IRB Committee - Review Participating Site Application

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

Regulatory Management: IRB Committee - Review Repository Application

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

Regulatory Management: IRB Committee Member Review

OverviewHuman 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.NavigationRole: Committee Member > Home Workspace

Regulatory Management: IRB Staff - Approve Repository Application

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.

Regulatory Management: IRB Staff - Review Participating Site Application

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.

Regulatory Management: Log in to eResearch

OverviewTo access eResearch Regulatory Management (eRRM), navigate to the eResearch website. You will need a uniqname, Sponsored account, or a Friend account and a UMICH password to log in.Important 

Regulatory Management: Manage Action Items

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.

Regulatory Management: Manage Documents (workaround for Finalize Documents)

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

Regulatory Management: MCRU Financial, Clinical & Lab Reviewers

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