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.
Category Archives: August 2022
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: 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.
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.
New Feature: Relying HRPPs receive a reminder when steps are incomplete, and the Investigator attests to the PI Survey
Relying HRPPs will receive an email notification, “Local Considerations reminder”, if they still have incomplete steps when the Investigator attests to the PI Survey. Incomplete steps include: Indicate Reliance, Confirm Institutional Profile, and Complete HRP Survey.
Updated Feature: The Participating Site Dashboard “To Do” list has been updated to reflect steps no longer required
The ‘Verify Study Team Access’ and ‘Validate PI Survey’ steps will no longer show on the Participating Site Dashboard’s “To Do” column. Those steps are no longer required for Relying HRPPs.