Lead Study Teams and Coordinating Center Staff will now be called “IREx Study Managers”. IREx Study Managers play a vital role in tracking Participating Sites’ as they navigate the reliance process. The new IREx Study Manager Checklist outlines how Study Managers can manage their Participating Sites, manually notify site HRPPs and PIs of the study in IREx, export Local Considerations for submission to the sIRB and upload Participating Sites approval documents to IREx. IREx Study Managers should be sure to talk to the Reviewing IRBs about how they plan to leverage this role to support the study in IREx.
Category Archives: IREx Study Manager
Bug Fixes – July 21, 2018
| Fixed: The Status Summary Tab has been updated to better distinguish component site reliance progress as distinct from the FWA holder. |
| Fixed: IREx has been updated to allow the Lead Study Team to export local context on studies where there are no coordinating center staff listed. |
Update: Status Summary Now Includes Dates of HRPP Activity
To better inform the Reviewing IRB and Coordinating Center / Lead Study Team, the Status Summary Tab now tracks when Participating Site HRPPs 1) are “contacted” about a study in IREx, 2) “start” the reliance process by accessing the study in IREx and, 3) “complete” their cede decision in IREx.
Bug Fixes – June 19, 2018
Fixed: For study-wide amendments and continuing reviews, the Reviewing IRB determination letter and dates of submission, review and approval for the lead site / overall study are copied over to Participating Site approvals to expedite the upload process for Reviewing IRBs or Coordinating Centers / Lead Study Teams.
Update: Verifying the Participating Site Contact List Document
To help Participating Sites identify their site PI, IREx has updated the Edit Participating Sites window to require the Reviewing IRB or Coordinating Center / Lead Study Team to upload an updated participating site contact list document whenever a new site is added.
New Feature: Local Context Module 2
IREx released a second local considerations module to accommodate studies where consent documents are created by the Reviewing IRBs / Coordinating Centers. In this new module, Participating Sites will enter their local consent language directly into IREx as they would like it to appear on the consent form. Then, the final consent document will be generated on behalf of Participating Sites by the Reviewing IRB or Coordinating Center. Additionally, this new local context module provides a CSV download of all survey responses.
New Feature: Getting Started Checklists
IREx released user-specific checklists (“Getting Started Checklists”) on each study to help IRBs and study teams navigate their reliance-related steps. The checklists are role-specific and auto-hide once all the steps have been completed for a given study.
View Getting Started Checklists here.
New Feature: New Coordinating Center Staff Role
IREx has created a new user role called the coordinating center staff (CC Staff). This role is assigned by the Reviewing IRB Liaison. The CC Staff is typically the coordinating center contact or a member of the Lead Study Team who is responsible for managing Participating Sites in IREx.
CC Staff have the ability to add or remove sites to the study and upload approvals for Participating Sites as they are received. These users also have access to the Status Summary Tab to track Participating Sites through the reliance process until they are ready for sIRB review.
New Feature: Status Summary Tab
The Status Summary Tab provides an overview of status of all Participating Sites listed on a study. Use this tab to track each site’s progress towards sIRB review as they sign on to the required agreements to begin reliance and indicate reliance on the Reviewing IRB. This tab is available to the Reviewing IRB Liaisons and Lead Study Team Members.
System Enhancements – March 3, 3017
Enhanced: Reviewing IRB Liaisons and IREx Study Managers can list individual Participating Sites on a study in IREx without creating a network or consortium.