Regulatory Management

OverviewIn addition to filtering information in a table to search for an entry or a list of related entries, you can further personalize how data is displayed in a table using personalization. Available on project listers, activity logs, and custom searches, you can use this feature to choose to:

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, unless the study is Not Regulated or Exempt. Exceptions:

OverviewThis document covers the steps for non-UM users (individuals external to U-M) to access the eResearch Regulatory Management (eRRM) system. The first step is to obtain a Friend account or a Sponsored account. Then, an existing eRRM user creates an eResearch account (using the new Friend or Sponsored account ID).

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.

OverviewIn 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 member roles include:Co-InvestigatorFaculty AdvisorStudy Coordinator/Project ManagerAdministrative StaffResearch Staff​Biostatistician​ConsultantOtherIndividuals assigned to these roles:

OverviewThe 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 COI and CRAO Ancillary Committee members can advance a submission to the next required reviewing body prior to completing ancillary committee review by executing the Advance for IRB Review activity. This pauses the COI or CRAO committee's review and engages the IRB to begin their review of the submission. Ancillary Committee review and approval is required before the submission can be approved.

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