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.
Category Archives: Local Considerations
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.
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: Letter of Reliance now included in Local Considerations Export
The Letter of Reliance is now included in the Local Considerations Export for sites, along with the HRP and PI Surveys, the SSRP, and the Institutional Profile.
Updated Feature: PI Survey Edit/Attestation Dates available on PI Survey PDF Export
The PDF Export of the PI Survey contains a table displaying any dates the PI Survey was edited and the initial attestation and any subsequent re-attestations that were completed.
Updated Feature: The Status Summary tab now shows PI Attestation date
The local considerations section on the Status Summary tab now shows when the PI Survey is “Awaiting PI Attestation” and the PI Attested date.