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.
Category Archives: FRL
System Enhancements – May 31, 2018
Enhanced: IREx will send an email notification to the Participating Site HRPPs when the Reviewing IRB makes edits to the study specific reliance plan (SSRP) to reflect any site-specific changes requested.
Bug Fixes – May 31, 2018
Fixed: To reduce email traffic for Participating Sites, study expiration notices will no longer be sent to the Participating Site HRPPs and Study Teams. Instead, one notice will be sent to the Reviewing IRB Liaisons at 90, 60, 30 and 7 days to expiration or until a new approval is uploaded.
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.
Bug Fixes – April 25, 2018
| Fixed: IREx now allows PIs to make changes to the PI survey even after it has been completed as long as it has not been validated the HRPP Liaison. HRPP Liaisons can also edit completed PI surveys as long as the site has not received approval from the Reviewing IRB. If changes are made, the Lead Study Team / Coordinating Center is also notified of the changes. |
| Fixed: IREx now allows Participating Site HRPPs to make changes to local considerations surveys even after they have been completed as long as the site has not received initial approval from the Reviewing IRB. If changes are made, the Lead Study Team / Coordinating Center is also notified of the changes. |
| Fixed: IREx has updated the Participating Sites window to better identify sites that do not have access to IREx. These sites are labeled “Not in IREx” and colored grey in the Edit Participating Sites window. |
| Fixed: IREx has separated the “Add Study Contacts” step from the “Edit Review” step to allow study teams to be added before the study is ready for approval. |
Update: SMART IRB Exchange becomes IRB Reliance Exchange (IREx)
We are excited to announce that we are transitioning SMART IRB Exchange to a new name: IRB Reliance Exchange (IREx). We hope this new name helps clarify that IREx is a tool used to facilitate the single IRB review process that is distinct from, but can be used with, the SMART IRB Agreement.
Bug Fixes – March 14, 2018
| Fixed: The Institutional Profile has been updated to allow up to 15 component sites to be individually listed. |
| Fixed: IREx has updated the site review window to require minimal risk categories only when a minimal risk study is reviewed by expedited review |
System Enhancements – March 14, 2018
Enhanced: Links to the IREx Resources page and to the IREx trainings sign up are now available under the resources section of the home page. As always, the link to the Resources page is also available on the top right of every page in IREx.
Enhanced: For study-wide amendments and continuing reviews, the Reviewing IRB review dates for the lead site / overall study are copied over to Participating Sites approvals to expedite the upload process.
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.