Previously, only the sIRB could upload the initial approval. Now, study managers can upload the initial approval after the sIRB confirms the Study-specific Reliance Plan (SSRP). The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will appear on the Study Manager’s checklist when available for upload.
Categories & Users Impacted: Getting Started Checklist, Approvals, September 2022, Reviewing IRB, IREx Study Manager
The sIRB liaison(s) for a study will receive an email notification when the study manager has published the Overall Study/Lead Site Initial Approval. The subject line of this notification reads, “FYI: Overall Initial Approval Uploaded to IREx”. All study managers are also CC’ed on this email. No action steps are associated with this notification.
sIRB liaisons receiving notifications for a study will receive an email notification when the study manager has published any study-wide approval (e.g., Continuing reviews and study-wide amendments) in IREx. The subject line of this notification reads “FYI: Overall Approval Uploaded to IREx”. Study managers are also copied on this email. The email will list the type of approval and provide a link to the study. No action steps are associated with this notification.
The ‘Track Site Progress on Status Summary’ step on the study managers’ Getting Started Checklist has been renamed to ‘View Site Progress on Status Summary’. This step is available once a site has been added to the study.
The ‘Add PI Info’ step has been removed from the study managers’ Getting Started Checklist to help streamline other actionable steps. The sIRB liaison and study manager can add PI information from the Edit Participating Site dialog when listing a site and from the Status Summary tab before notifying the sites’ access to the study.
To help study managers prioritize their actions, the ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will not appear at the top of the Study Managers’ Getting Started Checklist when an initial approval, continuing review, or study-wide amendment is in progress. These steps disappear after the overall approval is published.
| Fixed: Accurately display Combo Sites on Add/Edit Participating Sites dialog. |
| Enhanced: The Reviewing IRB and Study Manager will see an alert when a study-wide amendment change summary character count exceeds 3999 characters. |
| Fixed: PI Survey Attestation date on Status Summary Export accurately matches PI Survey Attestation date on Status Summary Tab. |
| Fixed: PI(s) are listed on Relying HRPP Dashboard before HRPP registers for study. |
| Fixed: Study Manager Dashboard now shows the number of sites on the study after sites are added. |
