Reviewing IRB Liaisons can now give relying site coordinators access to their studies. Previously, only Study Managers were allowed to grant site coordinator access. Reviewing IRBs and Study Managers can give site coordinator access from the Participating Personnel dialog via the ‘+Grant Site Coordinator Access’ button and from the ‘+Add Site Coordinator Access’ button on the Approval History tab.
Category Archives: Coordinator
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: 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.
Updated Feature: Protocol document not included in the sort filter
On both the Study-wide IRB Approvals and the Approval History tab, the protocol is now pinned at the top of documents and not included if sorted. This is to help make it easier for users to find the protocol after sorting.
New Feature: SIRBs and Study Managers can Add Site Coordinator Access to IREx
IREx now allows sIRBs and Study Managers to give coordinator access at sites that have registered for their study. For convenience, sIRBS and Study Managers can give coordinators access from:
- the Approval History tab, select the site from the View As dropdown and select +Add Site Coordinator Access from the site menu.
- the Participating Personnel dialog, select the +Grant Site Coordinator Access.
View this Add Site Coordinator Access Quick Guide for reference.
New Feature: SIRBs and Study Managers can give a new Site PI Access to IREx when adding a Site Amendment
If a site PI is changed after the site receives initial approval, sIRBs and Study Managers can give the new PI study access via a site amendment. This avoids asking the relying HRPP to login to IREx and add the new PI.
View this Add Site Amendment Quick Guide for reference.
New Feature: An email notification is sent to the PI when a new coordinator is added at their site.
When a sIRB or Study Manager gives a site coordinator access to their study, an email notification, “New Coordinator Added” is sent to the PI. The email lists the study title, the sIRB Liaison or Study Manager who added the coordinator, site name, new coordinator name and email, and link to the study.