Relying site study teams now have a ‘Awaiting Reviewing IRB Approval’ step on their Getting Started Checklist. This step was added to let the PI and Coordinator know that after completing their steps in IREx, the next step is waiting for the sIRB to approve their site.
Category Archives: Study PI
Updated Feature: Renamed ‘Add Site Coordinator Access’ from the Approval History tab
The ‘Add Site Coordinator Access’ menu option on the Approval History tab, has been renamed to ‘Add Study Team Access’. The Reviewing IRB and Study Managers can now give additional or new PIs access to the study using the ‘Add Study Team Access’ dialog at any time. Previously, they were only able to give coordinators access.
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: Site Coordinators will now be cc’d on emails to the PI
Coordinators will now be included on email notifications to the PI except for the PI’s access and login email.
Updated Feature: Introducing the Refreshed IREx Study Page with Streamlined Navigation
The IREx Study Page has a new look! All users will see the study title is now at the top of the study page, an info icon that contains study information and primary contacts, and a top navigation bar that provides quick access to frequently accessed pages.
The navigation bar includes easily accessible pages:
- Approvals Page: Stay on top of your study’s approvals with just a click! Effortlessly view and manage all the approvals associated with your study in one centralized location.
- Status Summary Page: Monitor the status of your study at a glance! The Status Summary page provides a comprehensive overview of your study’s progress, helping you track milestones and stay organized.
- Sites Page: [Reviewing IRB & Study Manager only] Access the Sites page directly from the top navigation bar to easily manage your sites; add/edit sites and include study team contact information for each site.
- Contacts Page: [Reviewing IRB & Study Manager only] Stay connected with key study personnel! Access the Contacts page to view study team contacts who have access to the study.
Updated Feature: Prevent Study Managers from being added as a relying site study team member
IREx will now prevent Study Managers from being added as a study team member (Coordinator or investigator) to a participating site on the same study. This will ensure all users have the appropriate access and Getting Started Checklists.
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: 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.