On EFIC studies, the Study Manager Checklist step ‘Upload Relying Site Approval’ will be renamed to ‘Upload Relying Site Accepted CCP or Approval’. This is to let the Study Manager know a site can either receive the Reviewing IRB’s acceptance of their local Community Consultation Plan or receive initial study approval depending on which stage the site is at in the EFIC process.
Category Archives: FRL
Updated Feature: PI and Study Team Members Checklist for EFIC
The PI and Study Team Members’ Checklist will include new steps when participating on an EFIC study. The steps include Awaiting CCP Acceptance and Upload the CCP Summary of Results.
Bug Fixes – September 2, 2024
| Fixed: Relying HRPP Liaison has the option to view and edit the PI Survey as needed |
| Fixed: Updated the sIRB instructions file in the Onboarding tab to correctly display if indemnification is required for a study |
Bug Fixes – August 5, 2024
| Fixed: Study Managers can add a new site contact when adding site amendment |
| Fixed: Removed ‘Not Designated’ option to select as a sponsor |
Updated Feature: Participating Site report now separated by review type
The Participating Site Report is now separated by review type (Initial & Closed, Continuing Review, and Amendments). Reviewing IRBs can access the reports from the Export menu on the Reviewing Site’s Studies Dashboard. Relying HRPPs can access their reports from the Participating Site’s Studies Dashboard.
Updated Feature: The Sites page now displays Non-Engaged Sites
Relying HRPPs that have declined engagement during study registration, will now appear as “Non-Engaged Sites” in the blue box on the Sites page. These sites will no longer appear in the dropdown list to prevent the sIRB and Study Manager from adding the declined sites to the study. Reviewing IRBs and Study Managers can add a non-engaged site back on the study by going to the Status Summary tab to re-enlist the site.
Bug Fixes – June 3, 2024
| Fixed: Added a scroll to the Closed Sites dialog to view all closed sites on the study. |
| Fixed: Removed the menu on the Approval History tab for sites that are closed to prevent taking action |
| Fixed: Removed the survey downloads from the My Site Info button for studies not collecting Local Considerations. |
New Feature: The ‘Onboarding’ Tab is now available on all studies
Previously called the ‘Documents’ tab, the ‘Onboarding’ tab is an easily accessible place for Relying Sites to find any additional documents (i.e., Reviewing IRB SOPs, Reviewing IRB Communication Plans, Part 2 Consent Forms) that were uploaded by the Reviewing IRB or Study Manager to help facilitate sites’ local submission process.
Reviewing IRBs and Study Managers can upload additional documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.
Relying Sites that do not have initial approval will default to the Onboarding tab when accessing the study page. Relying sites will be able to access these documents, along with their sIRB instructions, for the life of the study.
Update Feature: Updated the sIRB Instructions to reference the ‘Onboarding’ tab
Sites receive the sIRB instructions in the “IREx Access and Single IRB Instructions” email when they are notified about the study. The purple text on the sIRB Instructions has been updated to say, “The overall/lead site approval is available in IREx on the Approvals tab of the study page. Use the Onboarding tab to view any additional documents shared by the sIRB and/or lead study team. Use these documents to prepare your local submission and initiate the reliance process at your site.”