Category Archives: Getting Started Checklists

Updated Feature: PI Checklist Now Includes Study Team Step

When a PI logs into IREx, they see their Getting Started Checklist on the left-hand side of the screen. A new first step has been added: Add/Edit Study Team. Any study team members added by the Study Manager or Reviewing IRB are listed in the dialog. The PI can confirm these members and/or add additional PIs and Coordinators in this step. Team members entered by the Study Manager or the Reviewing IRB will not have access to the study on IREx until the PI confirms this dialog. This new step facilitates participating study teams’ access to IREx.

Updated Feature: Getting Started Checklist Revamped

Some steps of the HRPP Getting Started Checklist can be edited after you have completed them. To make this clearer, we added a pencil icon to those steps. HRPPs will see a pencil next to Add/Edit Study Team, Confirm Institutional Profile, Complete HRP Survey, and Validate PI Survey. We also added a “See Status Summary” link on the participating site HRPP and study team Getting Started checklists to provide quick access to the Status Summary tab, which is now available to all participating sites on a study.

New Feature: Participating Sites can View Status Summary

Participating Site HRPPs and Study Teams now have a new tab “Status Summary” tab where they can visualize their site’s progress completing the steps towards sIRB approval. This tab is view only – no actions are completed on the tab. Participating Site HRPPs and PIs will continue to complete their steps on the Getting Started Checklist, which also has a navigation link to the Status Summary called “View Status Summary”. This feature is expected to bring transparency and clarity to participating sites as their HRPPs and study teams works towards reliance.

Updated Feature: Local Considerations Complete Notification Now Includes Outstanding Steps

In May we added “Complete Agreements” to the Relying HRPP Getting Started checklist. This feature allows sites to document and complete local considerations while their legal counsel is reviewing and executing any outstanding agreements, if needed. Sites are not allowed to document reliance or cede review until the agreements are complete, but, if a site completes local considerations before their agreements are complete, we now include in the email any outstanding steps that should be completed before the site is submitted to the sIRB for review, such as “Complete Agreements” or “Cede Review”.