eResearch

OverviewThis 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

OverviewFor 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:

Overview The question "Is Continuing Review required for this application?" displays on the bottom of the activities for Expedite, Record Expedited Decision, Full Committee, and Record Committee Decision, and on the associated Reviewer Checklists (Primary, Secondary, and Regulatory Reviewers). See the examples below.

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.

Overview A Continuing Report (CR) is used to renew the approval of a participating site application. Study teams receive an email reminder that their site application is due for a scheduled continuing review 30, 60, and 90 days prior to the study expiration date.  A CR can be created by personnel with edit rights on the approved participating site application, but only the Principal Investigator can submit it for review. Only one Termination Report or Continuing Report for a site application can be in progress at a time.

Overview A Termination Report is used only for terminating an approved participating site application upon completion of the research or for other reasons, such as low accrual, toxicity, funding, etc. Once the report is finalized, the site application will be terminated and archived. Once archived, you cannot modify or use the site application for research going forward. Important Only one Termination Report or Continuing Review for a site application can be in progress at a time.