Site Coordinators now have a Getting Started Checklist when accessing a study page. If the study is collecting local considerations via IREx, Coordinators will see a Getting Started Checklist with the following steps:
The Getting Started Checklist for Relying HRPPs and Investigator no longer requires verifying study team access. If a Study Manager adds a site Coordinator when initially adding the site to a study, that Coordinator now gets access to IREx when the Relying HRPP registers for the study in IREx, rather than waiting for the Relying HRPP or Investigator to verify their access. Relying HRPPs and Investigator have the optional step to “Add/ Edit Study Team Access” as needed.
The “Complete PI Survey” step on the PI’s Getting Started checklist has been renamed to “Complete/Attest to PI Survey”.
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.
Relying Site PIs have a checklist to guide them through their required steps in IREx – verifying local study team access and completing their PI Survey. The checklist now includes hover text that appears if they have skipped a step, and a pencil icon beside steps that can be edited (i.e., the PI Survey before the HRPP has validated the survey).
The Study Manager (SM) is typically responsible for ensuring participating sites document all reliance and local review information for the sIRB. To help facilitate this documentation, “Track Site Progress on Status Summary” is now a discrete step on the SM’s Getting Started Checklist and it routes the SM to the Status Summary Tab when clicked. Additionally, Study Managers will now see a pencil icon beside “Add Participating Sites” and “Add PI Info” since this information can be updated at any time.
When an SIRB offers an IAA or MOU on a study, it will be reflected on the Relying HRPP’s Getting Started checklist. The agreement must be negotiated and executed outside of IREx. The agreement will appear complete in the Getting Started Checklist after the SIRB enters a date executed for the Relying Institution.
As of March 2020, Study Managers can upload Continuing Reviews and Study-Wide Amendments on behalf of the sIRB. This month we improved their Getting Started Checklist to avoid some confusion. The steps “Upload Overall Study Approval” and “Publish Approval” disappear from the checklist once Study Managers have done these steps, so they know they are complete for that review and the next step is to upload approval for relying sites
To view or add other study team members to a study in IREx, Relying HRPPs or PIs press “Verify Study Team Access” in their Getting Started Checklist.
Additionally, we rearranged the Study Team Contacts dialog to make it easier to see which study team members already have access to the study. Now users with access are listed on the left side of the dialog, and you can add new users using “Add A Contact” on the right side of the dialog.
The site contacts (e.g., PI or Coordinator) listed by the Study Manager will auto-fill as members of the study team when the Participating Site HRPP registers for a study. This allows the HRPP Liaison to confirm existing contacts, rather than having to re-enter the contact information. After the HRPP liaison has registered and confirmed the contacts, they receive access to IREx and the study. After a site has registered, the PI and Coordinator information is locked to the Study Managers, so the site edits personnel if needed.
