Training and Reference Materials

Training

The Institutional Review Board offices offer classroom instruction on the basics of using the eResearch Regulatory Management (eRRM) system to create and submit human research subject applications (and more). Click the applicable link below to view the training schedule and enroll in a class:

Reference Materials

General References

These documents apply to all eRRM users:

Procedure Documents & Tips

Click a role name to display links to the training documents.

Expand/Collapse PI and Study Team
Procedure Description
PI & Study Team Quick Reference Card PDF icon Summary of basic eRRM tasks including creating and submitting a research study application.

eRRM basics:

Create an eResearch account and log into eRRM. Non-UM colleagues obtain a Friends Account to access eRRM.
Identifies features and functions on the "Home Workspace" (i.e., Study Team home page).

Creating an Application:

Create a study application and save it with a HUM number.
Enter study team members in the study application; includes selecting their role and appointment for the study and setting an email option.
Indicate the external or internal sponsor for a study application.
Enter notes in an application section for other study team members.
Post messages to anyone with access to the Study Workspace (e.g., IRBs, Core Committee staff).
Change the Principal Investigator (PI) on a study application.

Working with Documents in an Application:


Upload, edit and delete documents in a study application.
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:


Verify required sections are complete; check for errors; notify study team members to accept their role; notify the PI to submit the application.
An overview of changes related to COI begining 4/14/2014 for PIs, Study Teams and Study Coordinators.
Team members must accept their role on the study to submit the application.
Team members not affiliate with U-M must accept their role on the study and provide Conflict of Interest information to submit the application.
Allows study team members to move application to "Ready to Submit" section of PI's Inbox.
Details steps for the PI to submit the study application.
(Optional) Details steps for printing the study application.
Verify the status of a submitted study application.
Re-submit an application after making changes requested by a review committee.
Re-submit a study application when contingency information is required for approval.

Approved Study Changes:


Submit changes on an approved study (i.e., amend a study).
Submit adverse events (AEs) or other reportable information/occurrences (ORIOs) on an approved study.
Look up the number and type of Adverse Events reported for a particular study.
Submit a request for a continuing review on an approved study.
Clone (i.e., electronically copy) an application to begin a new one.
Expand/Collapse Core IRB Staff
Procedure Description
Submission Review QRC Assign a core staff owner; complete and submit the reviewer checklist; assign submission to reviewer(s) and/or committee(s).
Managing Meetings QRC Schedule a meeting; edit discussion items and agenda; record minutes and committee decisions.
Validating Committee Decision QRC Complete decision-validations; edit/send approval letters; finalize documents.
Administrative Withdrawal Remove submissions that no longer need to be stored in the system.
Using Fast Find Recommended method for searching for submissions. (Minimal impact on system-processing speeds)
Add Submissions to Hotlist Identify priority submissions and complete common tasks without navigating to the submission workspace.
Reassign Designated Contingency Review Covers options for reassigning contingency review of a submission to someone other than the originally designated reviewer.

SSRS Reports

SSRS Quick Reference Card

Print SSRS Report

Install ActiveX (Internet Explorer)

Export SSRS to Excel

Running, printing, and exporting SSRS reports in eRRM.

Manage Action Items

Manage Documents (workaround for Finalize Documents)

Roll back FAQ

Guide Modules (Updates Pending) PDF Doc  
About the Guide Modules   Click this icon to launch more information about the Guide Modules for Core IRB Staff
Module 1: Core Committee Basics Click this icon to launch Module 1: Core Committee Basics in a printable PDF format  
Module 2: Reviewing Online Submissions    
Module 3: Changes and Correspondence Click this icon to launch Module 3: Changes and Correspondence in a printable PDF format  
Module 4: Printing an Online Submission Click this icon to launch Module 4: Printing an Online Submission in a printable PDF format  
Module 5: Managing Meetings Click this icon to launch Module 5: Managing Meetings in a printable PDF format  
Module 6: Validating Decisions Click this icon to launch Module 6: Validating Decisions in a printable PDF format  
Administrative Withdrawal and Termination Click this icon to launch Administrative Withdrawal and Termination in a printable PDF format  
Expand/Collapse Core Committee Member/Reviewer
Procedure Description
IRB Committee Member Review Click this icon to launch Using Fast Find in a printable PDF format Complete and submit reviewer checklist.
PRC Committee Member Review Click this icon to launch Using Fast Find in a printable PDF format Complete and submit reviewer checklist.
Adverse Event - Single Member Review Click this icon to launch Using Fast Find in a printable PDF format Complete and submit reviewer checklist.
View Agenda Items Click this icon to launch Using Fast Find in a printable PDF format View and/or print committee meeting agenda.
Non-Committee Member - Submission Review Click this icon to launch Using Fast Find in a printable PDF format Complete and submit reviewer checklist as an ad-hoc reviewer.

Expand/Collapse Ancillary Committee Member/Reviewer
Quick Reference Card Description
Ancillary Committee Review QRC Click this icon to launch Using Fast Find in a printable PDF format Review a new study application; review an amendment; view adverse events (AEs) and scheduled continuing reviews (SCRs).
Procedure  
Complete Guide (Updates Pending) An overview of Ancillary Committee Reviewer procedures for reviewing human subject research in eRRM.

Expand/Collapse Institutional Biosafety Committee (IBC)
Procedure Description
Committee Member Review Complete and submit reviewer checklist for new study applications and/or IBC registrations.
Committee Member Review Submitted Changes Review changes submitted by the study team.
IBC Staff Review Complete initial review of submission; request changes from study team, if needed; assign to committee meeting for review.

PI/Study Team:

Creating a New IBC Registration

 

Create a new Institutional Biosafety Committee (IBC) registration.

Responding to IBC-Required Changes

Edit a registration in response to changes requested by IBC.

Amend IBC Registration

Reqeust an amendment on an existing IBC registration.
Finding Approved Registrations Locate and view an approved registration in eRRM.
Expand/Collapse Repository Application
Repository Procedure Description

Repository Director / Personnel

Complete/Submit Repository Application

 

Complete and submit the Repository Application. Only the Repository Director can submit an application.

IRB Staff / Committee

IRB Staff Review Repository Application

 

Complete an IRB Staff review of a submitted Repository Application.

IRB Committee Review Repository Application Complete an IRB Committee review of a submitted Repository Application.