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: FRL
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.
New Feature: Downloadable Documentation of Reliance Letter
A PDF of the Official Documentation of Reliance Letter is now available as a download on the Site-Specific Info button on a given study. Participating Site HRPPs can also access this PDF from the Study-Specific Reliance Plan view. Click Site-Specific Info> View Reliances (SSRP)> Letter of Reliance. As always, the letter will continue to be included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP.
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.
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. |