The ‘Add PI Info’ step has been removed from the study managers’ Getting Started Checklist to help streamline other actionable steps. The sIRB liaison and study manager can add PI information from the Edit Participating Site dialog when listing a site and from the Status Summary tab before notifying the sites’ access to the study.
Category Archives: Getting Started Checklists
Updated Feature: The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will now appear at the top of the Study Manager checklist
To help study managers prioritize their actions, the ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will not appear at the top of the Study Managers’ Getting Started Checklist when an initial approval, continuing review, or study-wide amendment is in progress. These steps disappear after the overall approval is published.
New Feature: Coordinators now have a Getting Started Checklist
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:
- Start PI Survey
- Awaiting PI Attestation
- Add/Edit Study Team Access
New Feature: Relying HRPPs and Investigator are no longer required to verify study team access
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.
Updated Feature: PI checklist step has been renamed
The “Complete PI Survey” step on the PI’s Getting Started checklist has been renamed to “Complete/Attest to PI Survey”.
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: PI Checklist includes help text to guide PI through steps.
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).
Updated Feature: Study Manager Getting Started Checklist better reflects expected tasks.
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.
Updated Feature: Relying HRPP Getting Started Checklist reflects agreements offered by SIRB.
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.
Updated Feature: Improved Getting Started Checklist for Study Managers Uploading Approvals
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