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.