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
Category Archives: Reviewing IRB
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.
Updated Feature: Add descriptive text in Comment Bubbles for Sites
To clarify the Comment bubble function on the Status Summary tab, the button “Post” is now changed to “Save” when saving a comment. Descriptive text is also added in the Comment bubble dialog:
“Log and share internal notes with the Reviewing IRB Liaisons and Study Managers. No notifications are sent when a comment is posted.”
Updated Feature: The upload Continuing Review Notification includes Additional Guidance
The “Time to upload Continuing Review to IREx” email, sent to the sIRB and Study Manager, now includes updated guidance on uploading a study closure if the study is no longer active.
Updated Feature: Search box now searchable by FWA number on the Find other sites page and Agreement checker
Users accessing the ‘Find other sites’ page and ‘Agreement checker’ can now search a site by FWA number in addition to the site name.
Updated Feature: Allow a Site Closure for Sites Not Approved for a Current Version but have Initial Approval
Previously, sites can only be closed on a study if the site has approval on the current version. The sIRB and Study Managers will now have the [+ Add Site Closure] option for sites that have received initial approval, even if they are not approved on the current study version. The Sites Closed page will list the version that the site had their last approval.
Updated Feature: ICF and option to “Waive” consents are no longer required for Minimal Risk Studies
If a study is minimal risk, regardless of whether the submission type was Full or Expedited, the sIRB and Study Manager are not required to upload a consent document for the overall study approval and for relying site approvals. The waiver box does not have to be checked.