eResearch

Regulatory Management: Change Log and Audit Trail
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

Regulatory Management: Change the Principal Investigator (PI)
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 (e.g., 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 (AME) must be created. Navigation Role: PI/Study Team Member > Home Workspace > Study Workspace

Regulatory Management: Changes and Correspondence
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.

Regulatory Management: Cloning an Application for Cancer Center Studies
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.

Regulatory Management: COI Changes for U-M Study Team Members & PIs
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:

Regulatory Management: Committee - Review of IBC Applications
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

Regulatory Management: Compare (View Differences)
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.

Regulatory Management: Complete Participating Site Application
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:

Regulatory Management: Continuing Review No Longer Required
Overview

Regulatory Management: Core Committee Staff Basics
Overview This document provides information that Core Committee Staff members can use to manage submissions for human subject research in eResearch Regulatory Management (eRRM). Approval and Expiration Dates The following table details how approval and expiration dates are set in eRRM.   If it is determined that a Continuing Review is required, then the approval and expiration dates described below apply.