PI & Study Team Quick Reference Card pdf
Summary of basic tasks including creating and submitting a research study application.
eRRM Basics
- Log in to eResearch - Create an account and log in to eResearch Regulatory Management (eRRM).
- Obtaining a Friend Account - Non-UM colleagues obtain a Friend or Sponsored Account to access eRRM.
- Using the Home Workspace - Identifies features and functions on the "Home Workspace" (i.e., Study Team home page).
Creating an Application
- Creating an Application for a New Study - Create a study application and save it with a HUM number.
- Adding a Study Team Member - Enter study team members in the study application; includes selecting their role and appointment for the study.
- Adding a Sponsor - Indicate the external or internal sponsor for a study application and any related PAFs, UFAs, or Awards.
- Posting Notes for the Study Team - Enter notes in an application section for other study team members.
- Posting Correspondence - Post messages to anyone with access to the Study Workspace (e.g., IRBs, Core Committee staff).
- Changing the PI on an application - Change the Principal Investigator (PI) on a study application.
Working with Documents in an Application
- Working with Documents - Add, upload, edit/stack, compare versions and delete documents in a study application.
- History & Rollback - Roll back to a previous version of an uploaded document.
- Uploading CVs, Resumes, and Biographical Sketches - Add CVs, etc. in the application on behalf of the PI or Co-Investigator of a study. Upload a revised CV, etc. for yourself.
Submitting a Study Application
- Preparing a Study Application for Submission - Verify required sections are complete; check for errors; notify study team members to accept their role; notify the PI to submit the application.
- Conflict of Interest (COI) Changes for HUMs & Amendments - An overview of changes related to COI beginning 4/14/2014 for PIs, Study Teams and Study Coordinators.
- Accepting Your Role on the Study Team - Team members must accept their role on the study to submit the application.
- (Friend Account) Accepting Your Role on the Study Team - Team members not affiliate with U-M must accept their role on the study and provide Conflict of Interest information to submit the application.
- Move Study Application to "Ready to Submit" Inbox - (optional) Allows study team members to move application to "Ready to Submit" section of PI's Inbox.
- Submitting a Completed Application - (PI only) Details steps for the PI to submit the study application.
- Printing the Application - Details steps for printing the study application.
- Tracking a Submitted Application and Approved Documents - Verify the status of a submitted study application and view approved documents.
- Submitting Requested Changes - Re-submit an application after making changes requested by a review committee.
- Study Approval and Contingencies - Re-submit a study application when contingency information is required for approval.
- Upload Non-UM IRB Approval Documents - Indicate approval and upload documents for an Other IRB Review (ceded) application.
Making Changes to an Approved Study
- Creating an Amendment - Submit changes on an approved study (i.e., amend a study).
- Creating an Adverse Event/ORIO - Submit adverse events (AEs) or other reportable information/occurrences (ORIOs) on an approved study.
- Generating an AE Summary Report - Look up the number and type of Adverse Events reported for a particular study.
- Creating a Continuing Review - Submit a request for a continuing review on an approved study.
- Creating a Termination Report - Submit a request for terminating an approved study or expanded access application upon completion of the research.
- Creating a Termination - Submit a request for terminating an exempt study.
- Cloning an Application - (Cancer Center Applications only) Clone (i.e., electronically copy) an application to begin a new one.