Regulatory Management

Summary of changes in eResearch Regulatory Management version 9.0.
Overview Study team members, except Principal Investigators and those with an Administrative Staff role, 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. Navigation Role: Study Team Member > Home Workspace
Overview Proposal Approval Forms (PAFs), Unfunded Agreements (UFAs), Awards (AWDs) and/or Internal Sponsors (including department or PI discretionary funding) associated with the study can be added when the Application is in an editable State (e.g., Pre Submission). At least one of the support sections must be answered. Multiple forms of funding or support must be added one at a time. This procedure covers how to add a related PAF and Internal Sponsor.
Overview In addition to the Principal Investigator, other Study Team Members can be included on the application. Each Study Team Member can be granted rights to edit the application and be included in future correspondence related to the study. Study team roles include: Co-Investigator Faculty Advisor Study Coordinator/Project Manager Administrative Staff Research Staff​ Biostatistician​ Consultant Other Individuals assigned to these roles:
Overview The Administrative Withdrawal activity is used primarily as a “housekeeping” tool to remove submissions that no longer need to be stored in the system (e.g., when a submission has sat in a State of Changes Required for an extended period of time with no progress). The Administrative Withdrawal activity is only available for submissions in the following States:
Overview When an Adverse Event (AE) is reported by the study team, IRB Staff will assign it to the appropriate reviewer(s). Once an AE is assigned to you for review, it can be found under My Reviews in the Inbox of your Home Workspace. Navigation Role: Committee Member > Home Workspace
Overview Anyone with access to a study can run an Adverse Event (AE) Summary Report or Other Reportable Information and Occurrence (ORIO) Summary Report to see how many and what types of AEs/ORIOs have occurred. Navigation Role: PI/Study Team Member > Home Workspace > Study Workspace
Overview This document provides information that Ancillary Committee members can use to review submissions for human subject research in eResearch Regulatory Management (eRRM).
The following table provides explanation of how to interpret the possible combinations of values that can be encountered in the Appointment Selection Complete? and Student columns in Question 1.3.
Overview If a submission was approved with contingencies, and the contingencies addressed by the Study Team require a review by the committee members prior to final approval, then IRB staff can send the submission to a Designated Reviewer to complete the contingency review. Navigation Role: Core Committee Staff > Home Workspace