Previously, sites can only be closed on a study if the site has approval on the current version. The sIRB and Study Managers will now have the [+ Add Site Closure] option for sites that have received initial approval, even if they are not approved on the current study version. The Sites Closed page will list the version that the site had their last approval.
Category Archives: FRL
Updated Feature: ICF and option to “Waive” consents are no longer required for Minimal Risk Studies
If a study is minimal risk, regardless of whether the submission type was Full or Expedited, the sIRB and Study Manager are not required to upload a consent document for the overall study approval and for relying site approvals. The waiver box does not have to be checked.
Bug Fixes – December 1, 2021
| Fixed: Study Specific ORAs can now be saved on a study in IREx Setup. |
| Fixed: Users not affiliated with sIRB/ lead site can be added as SMs on a study. |
| Fixed: Correct logic for displaying “waive” option in approval dialog. |
| Fixed: Multi-site Liaisons can validate PI Survey. |
| Fixed: Errors saving site amendments. |
| Fixed: Add and save Coordinators in Participating Site Dialog. |
| Fixed: Able to edit review and uncheck consent as “waive”. |
| Fixed: Separate Admin study comments and site comments. |
| Fixed: “Re-enlist” button for the sIRB/ SM to add site that previously declined back on study. |
Updated Feature: More Flexible Combo Site Documentation
A Combo Site occurs when one study team engages multiple Federalwide Assurances (FWAs) for a given study. Because sIRBs often review and approve Combo Sites separately – so as not to delay study activation at one site – IREx has added new flexibility for Combo Sites.
Most importantly, sites in a Combo can now be reviewed and approved by the sIRB separately. To facilitate sites being reviewed by the sIRB as quickly as possible, the notification that local considerations have been completed for a site in a Combo is now sent to Study Managers and sIRBs instantly, rather than requiring all sites be complete. Additionally, after a site is reviewed and approved by the sIRB, the site’s approval can be posted to IREx instantly, rather than requiring all sites in the Combo to have approval before the documents can be posted. Given that combo sites may have separate consent forms or receive approval at separate times, combo site approvals are posted for each FWA/site, like the other sites on the study.
Updated Feature: One PI Survey per FWA engaged in a Combo Site
PIs will now complete a separate PI survey for each FWA in a Combo Site, with the option to copy their PI survey responses from the other site in the study. A separate PI survey allows for more accurate capture of the conduct of the study for each site in a combo. As with all sites on a study, the HRPP of a site in a Combo validates the PI survey responses
Updated Feature: Updated PI Studies Dashboard
Lead and Participating Site PI Dashboards have been updated to include the study title, PI’s local site name, Reviewing IRB, current study expiration date, and a To Do column that lists the next step for your site. The dashboard includes sorting and searching capabilities.
Updated Feature: Reworded Registration Questions for Sites in a Combo
When the Relying Site HRPP registers for a study and has been identified by the sIRB or SM as part of a combo site, the question that asks whether any other FWAs are engaged has been clarified.
Bug Fixes – November 1, 2021
| Fixed: Fixed the ability to sort documents by Type, Name, Date Added, and Size on past and current approvals. |
| Fixed: IRB approvals show all documents in one view. |
Updated Feature: Lead Site Initial Approval, Study Manager, and Expiration Date added to IRB Exports
New fields have been added to data exports for sIRBs and Relying Site HRPPs. The new field for Lead Site Initial Approval (dateInitialReviewApproved) can be used to analyze study progress, such as time from Lead Site Initial Approval to Relying Site Approval. Study Manager (studyManager) and Expiration Date (studyExpirationDate) fields may help with managing contacts and anticipating study events, respectively. Download and save csv exports using the “Export” dropdown on the top righthand side of both Reviewing Site’s Studies and Participating Site’s Studies dashboards.
Updated Feature: TIN Study Emails Identified
All emails for studies that are part of the Trial Innovation Network (TIN) now include the sentence “This study is part of the TIN” for added clarity and searchability.