Regulatory Management

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
Overview When a submission (Human Subjects Application or Amendment) is assigned to be reviewed by the Cellular Therapy Ancillary Committee, the submission displays in the reviewer’s Inbox tab. The reviewer can then review or postpone the submission, which moves the submission to the reviewer’s In Progress tab. Once Cell Therapy Ancillary Committee review is complete, it displays on the reviewer’s Completed tab. Navigation Role: Cell Therapy > Home Workspace
Overview This document outlines the steps to view information in the Change Log (audit trail) of Reviewer Checklists. Navigation Role: Committee Member > Home Workspace > Review Workspace
Overview Any study team member who has been granted editing rights can change the Principal Investigator (PI) on a research study. However, the method for changing the PI depends on the state of the submission. If the study application is in an editable state (Pre Submission), the PI can be changed directly by editing the application. If the study application is in a non-editable state (e.g., Approved), an Amendment must be created. Navigation Role: PI/Study Team Member > Home Workspace > Study Workspace
Overview This procedure covers how to request application changes and communicate with study team, core staff, and reviewers. There are multiple methods for Core Committee Staff to communicate with study teams, including requesting changes to the submission, sending correspondence, and adding comments directly to the submission. All change requests, correspondence, and comments are tracked in the eResearch Regulatory Management (eRRM) system for future reference.
Overview Important Information The option to clone an application is only available for Cancer Center studies. All documents attached to the original submission will be removed from the cloned application. Cloned applications are saved in the Pre Submission State. The Study Coordinator will receive an email notification with the ID of the newly created application. If a Study Coordinator is not assigned to the application, the notification will be routed to the PI. This process may take several minutes.
A Conflict of Interest (COI) section appears in the following activities for a human subjects study application (HUM) or an amendment (AME): Accept Role, Submit Application, and Submit Amendment. In 2014, the COI section changed to:
Overview IBC Applications assigned to a committee reviewer display in the IBC Applications Requiring Review list on the Inbox tab of the Committee Member Workspace. This document covers how to: Locate IBC Applications for Review View an IBC Application (View Project, View Differences, Application Summary) Submit Review Navigation Role: Committee Member > Home Workspace
Overview For Participating Site (SITE), Repository (REP), and Biosafety/IBC (IBCA) applications, "View Differences" functionality provides a way to see the changes between submitted application versions.
Overview A Participating Site Application is used to track data with human subject research conducted at another institution where University of Michigan (U-M) is the IRB of record. New participating site applications are completed and submitted to the appropriate review committee(s). A new Participating Site Application may be started and saved for completion at a later time. Navigation The Participating Site Application can be accessed via: