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.
Category Archives: April 2018
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. |