The document type, Other IRB Approved Documents has been renamed to “Additional IRB Approved Documents” to help differentiate from the “Others” document type – which are documents not approved by the IRB.
Category Archives: Study PI
Updated Feature: Site-Specific IRB Approvals tab now specifies Study-wide Amendments
The Site-Specific IRB Approvals tab now includes a “Study-wide Amendments” label to help clarify study-wide vs site amendments.
Updated Feature: Search box now searchable by FWA number on the Find other sites page and Agreement checker
Users accessing the ‘Find other sites’ page and ‘Agreement checker’ can now search a site by FWA number in addition to the site name.
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: 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.
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.
New Feature: sIRB Can Close Studies on IREx
sIRBs can now close studies that are complete on IREx by uploading the reason and date of closure, as well as the IRB determination letter. Closing a study notifies sites that the study has ended. The study remains accessible to all registered sites after a closure is posted, and all past approvals become read-only. A record of sites’ reliance details and a history of sIRB site approvals are still available in all IRB exports for metrics. For instructions on how to close a study, see our Quick Guide.
Here is what you will see for a closed study:
- Study page is grayed out with a Study Closed header at the top
- Status Summary Tab shows as Closed in Approval column
- IRB Dashboards show that a study has been closed
- Versions box shows that a study has been closed
- Exports show closed studies with date of closure
Updated Feature: New Approval email notification includes additional guidance for PIs and Study Teams
The “New IRB Approval For Your Site” email, sent when the SIRB or SM has documented a new approval, now includes updated guidance on how PIs and study teams can access approved study documents for their site.
Updated Feature: Updated training links
Training links have been updated to go to our comprehensive training page, which includes helpful live and on-demand (via YouTube) trainings for all users.