Category Archives: Approvals

New Feature: Improve the upload of Continuing Reviews and Study-wide approvals

March 14, 2022Approvals, FRL, IREx Study Manager, March 2022, Reviewing IRB

After the sIRB or Study Manager uploads and publishes an ongoing approval for the overall study / lead site, a pop-up banner appears on the study page:

“Success! All previously approved sites are now listed as Pending on the Status Summary tab. Visit the Relying Site Approvals dialog to confirm sites were approved and upload/remove site-specific documents, as needed. Completing this step will notify the sites of the new approval.”

The pop-up banner is used to prompt the sIRB and Study Manager that previously approved sites’ status has changed to “Approval Pending” and to confirm the sites were approved and update any approval documents.

Updated Feature: Hide Versions side bar on Study Page

March 14, 2022Approvals, Coordinator, FRL, IREx Study Manager, March 2022, Relying HRPP, Reviewing IRB, Study PI

The Versions side bar has been removed from the IREx study page. In the past, the Versions panel was used to locate past approvals but is no longer needed as sites can view all of their approvals on the Approval History tab. The sIRB and Study Manager can view all study-wide approvals on their Study-wide IRB Approvals tab.

Updated Feature: Sites can Download All approvals in one or by groups

March 14, 2022Approvals, Coordinator, FRL, IREx Study Manager, March 2022, Relying HRPP, Reviewing IRB

Relying sites can use the Download All button to download both the Global (study-wide IRB approved) and Site-specific Documents. Sites can also download groups of approval documents by using the corresponding Download button or individual documents by clicking the document name.

Updated Feature: Approval notifications include new Approvals Quick Guide

March 14, 2022Approvals, Coordinator, Email Notifications, FRL, IREx Study Manager, March 2022, Relying HRPP, Reviewing IRB, Study PI

All relying site approval notifications are updated to include text and a link to the Approvals Quick Guide for helping study teams locate their approval documents:

“*NEW* We’ve made accessing your approval documents more user friendly – use this Quick Guide to see changes.”

Updated Feature: Delete Version option removed from Closed Studies

February 1, 2022Approvals, February 2022, FRL, IREx Study Manager, Reviewing IRB

The Delete Version option has been removed from closed studies to prevent removing a closed status and resetting the study to an open version. Study closures in IREx can be re-opened by IREx Admins, if needed.

Updated Feature: Date Added is now Date Approved

February 1, 2022Approvals, Coordinator, February 2022, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, Study PI

For better clarification, the Date Added column has changed to ‘Date Approved’ to indicate the date documents were approved on the Study-wide and Site-Specific IRB Approvals tabs. SIRBs and Study Managers can also see the Date Approved column when uploading approvals for the Lead Site and Relying Sites.

New Feature: Ability to Edit Consents & Assents to Include a Descriptor for the Overall Study/ Lead Site Approval

December 30, 2021Approvals, FRL, IREx Study Manager, January 2022, Reviewing IRB

The sIRB and Study Manager now have the option to edit the names of Consents & Assents for the Overall Study/ Lead Site approval. After uploading Consents & Assents in the approval dialog, the sIRB and Study Manager can use the pencil icon next to the document type and a pop-up dialog will allow them to enter a descriptor (e.g., Consents & Assents – Spanish).

New Feature: Ability to Sort Documents Uploaded in the Overall Study/ Lead Site Approvals Dialog

December 30, 2021Approvals, FRL, IREx Study Manager, January 2022, Reviewing IRB

The sIRB and Study Manager can now sort documents that are uploaded in the Overall Study/ Lead Site Approvals Dialog. Documents can be sorted by Type and Document file name.

Updated Feature: Pop-up Dialog Added When Editing a Package Insert Document Type

December 30, 2021Approvals, FRL, IREx Study Manager, January 2022, Reviewing IRB

A pop-up dialog has been added when using the pencil icon to edit the Package Insert document type. The sIRB and Study Manager can now easily see they are adding a descriptor to the Package Insert document type (e.g., Package Insert – Notes) when uploading approvals for the Overall Study/ Lead Site.

Updated Feature: The Determination Letter Has Been Renamed to “IRB Approval Documentation”

December 30, 2021Approvals, Coordinator, FRL, IREx Study Manager, January 2022, Relying HRPP, Reviewing IRB, Study PI

The Determination Letter document type has been renamed to “IRB Approval Documentation” for better clarification since not all institutions call the approval from the IRB a determination letter.

Category Archives: Approvals

New Feature: Improve the upload of Continuing Reviews and Study-wide approvals

Updated Feature: Hide Versions side bar on Study Page

Updated Feature: Sites can Download All approvals in one or by groups

Updated Feature: Approval notifications include new Approvals Quick Guide

Updated Feature: Delete Version option removed from Closed Studies

Updated Feature: Date Added is now Date Approved

New Feature: Ability to Edit Consents & Assents to Include a Descriptor for the Overall Study/ Lead Site Approval

New Feature: Ability to Sort Documents Uploaded in the Overall Study/ Lead Site Approvals Dialog

Updated Feature: Pop-up Dialog Added When Editing a Package Insert Document Type

Updated Feature: The Determination Letter Has Been Renamed to “IRB Approval Documentation”

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