On the Status Summary Tab, the “Not Approved” status is now hidden until the site completes all steps needed for sIRB review. These steps include the completion of agreements, reliance decision, and local considerations if applicable for the study. This is to ensure a site has completed all necessary steps before site approval is uploaded.
Category Archives: Local Considerations
Updated Feature: Display Getting Started Checklists for study teams when given study access
PIs and Coordinators will now see their Getting Started Checklists when given access to a study. However, the ‘Complete PI Survey’ step will be unavailable until their HRPP registers for the study.
Updated Feature: The ‘isCollectingLocalContext’ column is now included in the Participating Site export
The Participating Site Report now includes, ‘isCollectingLocalContext’ column to indicate whether local considerations are expected for the study. If not, you will not see or expect any dates for the HRP Survey or PI Survey being completed. A one (1) indicates the study is collecting local considerations.
New Feature: Streamlined Local Considerations documentation for HRPPs
IREx has simplified local considerations documentation by no longer requiring Relying HRPPs to upload their locally verified site-specific ICF(s) to the HRP Survey. Now, Coordinators or Investigator can upload the locally verified ICF(s) to the PI Survey for the sIRB to review. HRPPs are also no longer required to validate their site’s responses to the PI Survey; however, responses can still be viewed and edited, if needed.
New Feature: Coordinators can complete the PI Survey in IREx
Site Coordinators can now complete PI Surveys in IREx on the investigator’s behalf. After a Coordinator completes the PI Survey investigators receive an IREx notification that the PI’s attestation is needed. Any edits made by the Investigator, Coordinator, or Relying HRPP after the initial attestation will require a new attestation.
New Feature: Investigators are notified when PI Attestation is requested
When a coordinator completes the PI Survey and clicks “Send to PI”, a notification is sent to the Investigator requesting review and Attestation to the PI Survey. This email is sent the first-time a coordinator completes PI survey.
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: PIs can click a button to attest to the PI Survey
Investigators are no longer required to add a signature to attest to the PI Survey. Investigator Attestation is captured the first time the Investigator completes and submits the PI Survey. If edits were made, Investigator attestation is captured when the Investigator clicks the “Attest to PI Survey” and “Edit and Attest” buttons.
New Feature: Investigators are notified when edits are made to the PI Survey
Investigator will receive an email notification when Relying HRPPs and Coordinators make edits to the PI Survey. Investigator must attest every time edits are made to the PI Survey.
New Feature: Study Managers receive a notification when the Investigator attests to the PI Survey
Study Managers will receive an email notification, “PI Survey Completed – Available for Prescreen”, the first time an Investigator at a site has attested to the PI Survey. This is so the Study Managers can go do a quality assurance check and ask for necessary edits, if desired.