| Fixed: Error removing site amendments |
| Fixed: Undo site closure |
Category Archives: FRL
Updated Feature: Delete Version option removed from Closed Studies
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: Primary Liaison Contact included in the Reviewing IRB’s Overall Study Export
The Reviewing IRB’s Overall Study Export now includes a column for the Primary Liaison contact, “reviewingIRBContact”.
Updated Feature: Date Added is now Date Approved
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
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
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
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”
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.
Updated Feature: Display Custom Document Type When Approval is Published
The sIRB and Study Manager can now customize/ relabel document types for ‘Additional IRB Approval Documents’ and ‘Others’. These document types will no longer have the word “Other” as a prefix in the title.
Updated Feature: Edits to Help Text When Customizing Document Types
Help text has been updated to, “Please describe the document type” in the pop-up dialog when the sIRB and Study Manager customize these document types:
- Consents & Assents
- Additional IRB Approved Documents
- Others
- Package Insert