Overview In some cases, submissions may be approved with contingencies. Prior to full approval, study teams must submit additional information to satisfy the contingencies. The study team receives a Contingencies Letter via email, which includes a link to the study. The Outstanding Issues table at the bottom of the Study Workspace lists all contingencies to be addressed. The Current State of the study is Contingencies Pending.
Overview Reviewers may request the PI/Study Team to make changes to a submission (e.g., Study Application, Amendment, Adverse Event/Other Reportable Information and Occurrence (AE/ORIO), Continuing Review, or IBC Application). These submissions appear in the Require Action by Study Team list under the My Inbox tab of your Home Workspace. The following procedure demonstrates submitting requested changes to Core Staff on a Study Application. The same steps apply for any reviewing body and submission type.
Overview Termination is available for exempt studies. By submitting the Termination, the terminated application can no longer be used or modified. Navigation Role: PI/Study Team Member > Home Workspace
Overview A Termination Report is used only for terminating an approved study or expanded access application upon completion of the research. Once the report is finalized, the application will be terminated and archived. Once archived, you cannot modify or use the application for research going forward. Navigation Role: PI/Study Team Member > Home Workspace
Overview This reference document shows how to verify the status of a submitted study application and view approved documents. Home Workspace - Approved Tab
Overview Study Team members with rights to edit the study application can upload or update biographical information, such as a resume, CV, or biographical sketch, for themselves or for other members of the study team. Often, Study Coordinators will update these items for the Principle Investigator and Co-Investigators. If you want to upload a revised CV for yourself, see the Edit section below. Important Information
Overview After the PI/Study Team receives approval from an external (Non-UM) IRB, the Study Team must indicate approval receipt in eResearch Regulatory Management (eRRM) by uploading supporting documents. Note Until this activity is completed, associated Awards in the eResearch Proposal Management System (eRPM) will remain in a Compliance Hold State.
Forms Menu (previously Jump To list) The bars Forms menu persistently displays a list of all sections and pages within an application. It allows you to jump directly to any section or page in the application but does so by ignoring the logic built into the smartforms.
Overview When you log in to eResearch Regulatory Management (eRRM), your Home Workspace displays. You can initiate a variety of activities, access other workspaces, and view any items that require your attention.