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.
Category Archives: FRL
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
Bug Fixes – January 1, 2021
| Fixed: Error when making a combo site from consortium on Participating Site Dialog. |
| Fixed: Editing version number when replacing draft protocol. |
New Feature: Add Participant box for Study Managers
Study Managers now have a “Participant” box added to their Dashboard menu to view the studies they are participating in as a relying site study team. The descriptive text next to the Participant box indicates , “Your site is a Participant in [#] studies”.
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: Site-Specific IRB Approvals tab now specifies Study-wide Amendments
The Site-Specific IRB Approvals tab now includes a “Study-wide Amendments” label to help clarify study-wide vs site amendments.
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.