As requested, the Study-Specific Reliance Plan (SSRP) is now included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP. Participating Site HRPPs can also download a PDF of the SSRP from the site-specific info button on a given study.
Category Archives: Reviewing IRB
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.
Update: Aligning the IREx Study-Specific Reliance Plan with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit
IREx’s Study-Specific Reliance Plan (SSRP) was harmonized with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit, which documents how the Reviewing IRB and Participating Site HRPPs will handle any flexible elements of the reliance agreement such as auditing, SOPs, insurance, external reporting, etc. This does not impact existing reliance relationships. The updated SSRP will only appear for studies created on or after April 25.
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: Capture Study-Specific Local Context from Participating Sites
IREx released a local context/local considerations module to allow Reviewing IRBs to centrally capture study-specific local considerations for each site, using standardized surveys and questions aligned with national sIRB initiatives.
The local considerations module has two surveys: 1) The Human Research Protections (HRP) survey asks about requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local site ancillary reviews, relevant to the specific study or trial that would affect the conduct or approval of the research at your institution, as well as the consent form for this study. This is completed by the Participating Site HRPP Liaison; and 2) the PI survey asks about the conduct of the study at your site and is completed by the Participating Site PI. The Participating Site HRPP must verify the PI 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: Multi-site Liaisons for users overseeing multiple FWAs
IREx supports institutions that oversee or provide HRPP functions for multiple FWAs using the Multi-Site Liaison feature. IRB/HRPP Liaisons can be set up as “Multi-Site Liaisons” to manage multiple FWAs with one user account. Multi-Site Liaisons can easily manage Institutional Profiles for each FWA, as well as indicate reliance and access approval documents each FWAs, even within a single study, in IREx. Contact the IREx team to be set up as a multi-site Liaison.
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.