From the Sites tab, the ‘Add Site’ dialog will now display a list of sites already listed on the study. This will serve as a quick glance to help the user reference what sites are already listed when adding new sites.
Category Archives: Edit Participating Sites
Updated Feature: Display engaged combo sites when editing site contacts.
Editing contacts for a combo site that has not been given study access will now show all engaged sites in the combo and can be modified.
Updated Feature: Display closed sites on the Sites page
sIRBs and Study Managers can now see if a site was closed on the Sites page.
Updated Feature: Include multiple study team contacts before notifying sites of a study
Lead Study Teams can now enjoy the flexibility of including multiple study team contacts before notifying sites of a study. IREx allows Lead Study Teams to list multiple investigators and/or ‘coordinators’ for each site involved in the study. This comprehensive approach enables you to include a diverse range of key personnel, such as regulatory specialists, clinical research associates, clinical research navigators, and more. Having multiple study team contacts enhances collaboration by keeping everyone informed, engaged, and up-to-date throughout the site onboarding process.
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: Survey available to request new consortiums to be added to IREx for IRB/HRPP Liaisons and Study Managers
Last month, a new feature was created to add a consortium of sites on the Participating Sites dialog so that study managers no longer have to add each site individually to their studies if the study is part of a consortium. To support this feature, we created a new survey where an IRB/HRPP Liaison or Study Manager can request a new consortium be added to IREx. The sIRB or Study Manager can also find a link to this survey on the Participating Sites dialog when they select to add a consortium.
Updated Feature: Add a consortium of sites to studies in the Participating Sites Dialog
The first step for Study Managers on IREx is to add participating sites. This step has been made easier for consortium studies with the “select consortium of sites” option. Inform the IREx Administrators if you would like to establish a consortium. Once created, the SM can simply add all sites from a consortium at once. Sites can also be removed; plus, non-consortium sites can be added to any study in addition to consortium sites.
Updated Feature: Email notification includes helpful guidance when new sites added
When a site that has not joined IREx is listed on a study, the “Participating Sites Added to Study” email now includes helpful text to guide how the site HRPP/IRB can initiate access for their site through the Join IREx page. This is an existing email sent to Reviewing IRBs and SMs if either party adds new sites to a study, but now updated for clearer guidance.
Updated Feature: An 8-digit FWA is now required when listing a new site that does not exist in IREx on the Participating Site dialog.
Occasionally an sIRB or Study Manager adds a site to their study that does not yet exist in IREx (i.e., the site does not pop-up when typing their name). The FWA number will be required to add this site to IREx, as this information helps ensure the institution has an active FWA, which is the minimum standard for participating. A link to the OHRP FWA database is provided for reference.
Updated Feature: Participating Sites Dialog distinguishes whether site has joined IREx.
In order to help sIRBs and Study Managers know they need to request a site join IREx before the site can provide reliance and local review documentation in IREx, the Participating Sites dialog will now include the following text for sites that have not signed the IREx Terms of Use:
Let this site know their HRPP/IRB needs to initiate IREx access for their site here.