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).
Category Archives: Reviewing IRB
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
Updated Feature: Other IRB Approved Documents Has Been Renamed to “Additional IRB Approved Documents”
The document type, Other IRB Approved Documents has been renamed to “Additional IRB Approved Documents” to help differentiate from the “Others” document type – which are documents not approved by the IRB.
Updated Feature: No Longer Required to Name Document Types Prior to Upload
When uploading the Overall Study/ Lead Site Approval, the sIRB and Study Manager are no longer required to enter text prior to uploading the following document types:
- Other IRB Approved documents
- Others
- Package Insert
New Feature: Mark site(s) as Not Enrolling
Some sites on studies are ‘engaged in research’, but they aren’t consenting participants. The question, “Is Site Enrolling?” is now added to the Overall Study/ Lead Site and Relying Site Approvals dialog. The sIRB and Study Manager can now mark when a site is not enrolling. The “Site Not Enrolling” indicator will be shown on the Study-wide IRB Approvals Tab for the lead site and for a site’s published approval. All sites marked as not enrolling will not require a consent form for upload. When a new approval version is created, the site’s enrollment status will carry forward and can be updated as needed.
Updated Feature: Remove Requirement to Name Document Prior to Upload for Lead Site Approval
For lead site approvals, the requirement to enter a description when uploading documents for Other IRB Approved Documents, Others, and Package Insert has been removed. The Reviewing IRB and Study Manager have the option to edit the name for those document types after upload.