When Reviewing HRPPs or Study Managers are uploading their approval documents, they must either ‘Accept’ the draft protocol or ‘Replace Draft.’ They can use the Replace Draft button to replace the protocol as many times as they need until the approval has been published. They still must ‘Accept’ the protocol before they can publish.
Category Archives: Reviewing IRB
Updated Feature: Managing Combo Sites
Reviewing IRBs and Study Managers can now easily modify their sites that engage multiple FWAs, known as Combo Sites in IREx. On the Sites tab, deleting a Combo Site will now display the Manage Combo Sites dialog, which allows you to select sites you want to delete and/or add a site by using the +Add Site button.
New Feature: IREx now supports Exception from Informed Consent (EFIC) studies
IREx now supports studies using the EFIC process. Using IREx to implement your EFIC workflow helps lead study teams track sites in various stages of the EFIC process; standardizes and centralizes EFIC documentation for the sIRB and relying HRPPs; and provides sites with clear EFIC processes and approval statuses. When setting up the study, Reviewing IRBs can select EFIC as an option in the IREx Setup. Study team can now upload their local Community Consultation Plan (CCP) to IREx’s PI Survey and Relying HRPPs can confirm review of the local CCP in the HRP Survey. After the sIRB reviews and accepts the site’s CCP, Study Managers can share the Reviewing IRB’s acceptance of the site’s local CCP to IREx and to begin implementing the plan. Watch this video and read this announcement to learn more.
New Feature: An ‘EFIC’ bubble displayed on study pages and on the list of search results is to indicate a study is an Exception from Informed Consent study
An ‘EFIC’ (Exception from Informed Consent) bubble appears next to study titles on each study page and when searching studies and to indicate which studies are EFIC-supported.
Updated Feature: Dates captured for EFIC studies now included on exports
The Participating Site Report and Status Summary Tab Report now includes columns that capture dates when the CCP was submitted, reviewed, and approved for an EFIC study. The exports will also include dates the study teams complete the CCP Summary of Results Survey and date PI Attested to the summary. 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. The Status Summary Tab Report is available for Reviewing IRBs and Study Managers on the Status Summary Tab.
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.
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.
New Feature: Reviewing IRBs can now request Relying Sites update their Local Considerations throughout the life of a study
In the IREx Study Setup, Reviewing IRBs/sIRBs can choose to have IREx notify relying sites when a study-wide amendment is posted, and request sites update their local considerations in IREx if necessitated by the study changes. If sIRBs choose this option, they can also opt to choose a number of days sites have to submit their updates in IREx. This feature is only available on studies in which the sIRB is collecting local considerations in IREx.
New Feature: Amendment Content can now be indicated when uploading a study-wide amendment
For studies capturing local consideration updates, Reviewing IRBs and/or Study Managers will see a new ‘Amendment Content’ section on the Add Study-Wide Amendment dialog. The content areas are informed by the SMART IRB local considerations guidance documents.