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
Category Archives: FRL
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.
Updated Feature: Clarified Pop-up when Removing Site Amendments
A Study Manager or sIRB can delete an erroneous Site Amendment by clicking on Remove Site Amendment on the Site-specific IRB Approvals tab and confirming the removal. The confirmation pop-up has been updated to inform the user that sites will not be notified when the Site Amendment is deleted.
Bug Fixes – October 4, 2021
| Fixed: PIs and Coordinators can view approval documents on Study-wide IRB Approvals Tab |
| Fixed: Study team members from the non-primary FWA of a combo site can view approval documents |
New Feature: sIRBs and SMs Can Close Sites in IREx
sIRBs and Study Managers can now close sites on studies. A reason or reasons for closure, date of closure, and determination letter are required to post a site closure. Closing a site sends a notification to the site’s HRPP and study team members and archives all past approvals so that no documents can be downloaded. Participating sites continue to have access to site closure documentation for 30 days after a site closure is submitted, after which the site cannot access the study in IREx. A listing of closed sites is available to sIRBs and Study managers on the Status Summary tab. For further information, see the Site Closure Quick Guide.
Updated Feature: SMs Can Close Studies in IREx
Study managers can now close studies that are complete in IREx, which was last month’s released feature for sIRBs. For instructions on how to close a study, see our Study Closure Quick Guide.