eIRB Training and Guidance

Support Materials for the Research Community

Developed and Maintained by the Success Center in collaboration with the Office of Research Integrity

• Consolidated User Guide - March, 2013 - detailed guide to create, submit and track initial protocols, modifications, continuing reviews and reportable events.
• eIRB States Chart - March, 2013 - definitions of the states of activities in the eIRB system, the personnel roles that can make changes when an activity is in a certain state and the types of eIRB forms that will have this the state.
• MUSC eIRB Quick Reference Guide for Investigators and Study Staff - December 2011 - 3 page reference guide on use of the eIRB system
• MUSC eIRB Quick Reference Guide for Protocol Navigation December 2011 - 2 page reference to understand the information displayed in the eIRB system
• MUSC eIRB - Departmental Guidance for Protocol Review
• MUSC eIRB - IRB Committee Guidance for Protocol Review

eIRB Tegrity Training Courses

As a supplement to guidance materials, provide demonstration of eIRB functions that
1. Highlight navigation features
2. Complete major tasks

To view these courses, speakers must be in use and Tegrity Player must be installed on your computer.  Installing this player will be an automatic prompting when you click on a link below to open a session.  To view the session in full-screen mode, select the icon that looks like a computer screen in top right corner of the box with the session’s name.  To minimize the session again, Press ESC.  Options to adjust the volume and play speed and control playback functions are at the bottom of the screen.

• Getting Started (3 min)
• Creating a New Study (11 min)
• Submitting a Study (2 min)
• Reviewing/Approving a New Study (Mentor/Department Approvers) (3 min)
• Responding to Department Comments (2 min)
• Responding to IRB Comments (4 min)
• Locating/Editing/Copying Studies (4 min)
• Protocol Navigation (4 min)
• Accessing IRB Reviewed Documents (2 min)
• Amendments (11 min)
• Watermarking Documents (3 min)
• Study Status Changes (4 min)
• Reportable Events (4 min)
• Continuing Review (3 min)
• Uploading Documents (5 min)

Link to the Training eIRB
UserID: musc-your netid (example is musc-mynetid)
Password: jek30rid

Link to Production eIRB

Current Training - Computer Hands on Sessions

Focus Audience - Principal Investigators and Research Study Staff - eIRB Hands-On training in the computer labs of the Education Center Library. Click on Registration Link to self-register. The goal of these sessions are for each participant to gain real-time experience in the eIRB system.

• Session I eIRB - IRB Study from Creation through Approval, including responding to IRB review comments and ultimate receipt of study approval
• Session II eIRB - Amendment, CR, AE and Status Change - Amending an approved study, completing continuing review, and notification of reportable events.

We are working to schedule additional sessions for 2013. Please check back!