The Study Manager (SM) is typically responsible for ensuring participating sites document all reliance and local review information for the sIRB. To help facilitate this documentation, “Track Site Progress on Status Summary” is now a discrete step on the SM’s Getting Started Checklist and it routes the SM to the Status Summary Tab when clicked. Additionally, Study Managers will now see a pencil icon beside “Add Participating Sites” and “Add PI Info” since this information can be updated at any time.
Category Archives: IREx Study Manager
Updated Feature: Study Manager Dashboard includes additional information.
For easier and quick reference, the Study Manager Dashboard now includes the IREx Project ID, which is also at the end of all IREx URLs for the study. Additionally, the Study Manager Dashboard now includes the most recent study approval date and the expiration date.
Updated Feature: An 8-digit FWA is now required when listing a new site that does not exist in IREx on the Participating Site dialog.
Occasionally an sIRB or Study Manager adds a site to their study that does not yet exist in IREx (i.e., the site does not pop-up when typing their name). The FWA number will be required to add this site to IREx, as this information helps ensure the institution has an active FWA, which is the minimum standard for participating. A link to the OHRP FWA database is provided for reference.
Updated Feature: Participating Sites Dialog distinguishes whether site has joined IREx.
In order to help sIRBs and Study Managers know they need to request a site join IREx before the site can provide reliance and local review documentation in IREx, the Participating Sites dialog will now include the following text for sites that have not signed the IREx Terms of Use:
Let this site know their HRPP/IRB needs to initiate IREx access for their site here.
Updated Feature: Continuing Review reminder notification cc’s Study Managers and clarifies what action is needed.
Study managers will now be cc’d on the email reminder sent out when a study is nearing the expiration date listed in IREx. This email notification serves as a reminder to upload the continuing review approval to IREx to ensure the approval statuses for sites stay up-to-date. The email also now includes a hyperlink to the quick guide for uploading continuing reviews.
Enhanced Feature: Study Managers Can View SSRP Documents from Status Summary
Study Managers can now use the Status Summary Tab, which provides an overview of sites’ progress completing the steps towards sIRB approval, to access Study-Specific Reliance Plan (SSRP) documents. Under the Reliance Decision column of the Status Summary, a site will have a green Completed status, which when clicked, will open the SSRP page. This page shows the SSRP survey responses agreed upon by the sIRB and site, a copy of the letter of reliance, and a PDF of the SSRP responses.
New Feature: Agreement Checker Available to All Users
Our newest IREx Feature, the “Agreement Checker”, is a dynamic report page allowing you to list potential participating sites to see if they have signed the SMART IRB reliance agreement, joined IREx, and signed the sIRB’s Letter of Indemnification, if applicable. The list can also be exported into a comma-separated values (CSV) file. The Agreement Checker can be of particular help to sIRB’s who want to contact sites to complete agreements before a study is created in IREx, or for study managers gauging site readiness and preparing reliance instruction for sites (sample here). The “Agreement Checker” is located under the Resources section on the IREx homepage after logging into IREx.
Updated Feature: Improved Getting Started Checklist for Study Managers Uploading Approvals
As of March 2020, Study Managers can upload Continuing Reviews and Study-Wide Amendments on behalf of the sIRB. This month we improved their Getting Started Checklist to avoid some confusion. The steps “Upload Overall Study Approval” and “Publish Approval” disappear from the checklist once Study Managers have done these steps, so they know they are complete for that review and the next step is to upload approval for relying sites
Updated Feature: Enhanced Status Type When Uploading Approvals for Study Managers and sIRBs
The approvals upload page has been enhanced to better highlight the study’s approval status (approved vs. pending) for sIRBs and Study Managers. The new page layout is more intuitive, showing the status as the first question.
Updated Feature: New Document Types on Approvals
Document types are used in IREx to help manage files associated with a study’s approval. For clarification, IREx has renamed Consents to Consents & Assents, and added document types for Grant Application, Measures, Recruitment & Advertisements, and Other IRB Approved Documents. The new categories will make it easier for users on IREx to find their study documents.