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.
Category Archives: Approvals
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.
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: 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.
Updated Feature: More Flexible Combo Site Documentation
A Combo Site occurs when one study team engages multiple Federalwide Assurances (FWAs) for a given study. Because sIRBs often review and approve Combo Sites separately – so as not to delay study activation at one site – IREx has added new flexibility for Combo Sites.
Most importantly, sites in a Combo can now be reviewed and approved by the sIRB separately. To facilitate sites being reviewed by the sIRB as quickly as possible, the notification that local considerations have been completed for a site in a Combo is now sent to Study Managers and sIRBs instantly, rather than requiring all sites be complete. Additionally, after a site is reviewed and approved by the sIRB, the site’s approval can be posted to IREx instantly, rather than requiring all sites in the Combo to have approval before the documents can be posted. Given that combo sites may have separate consent forms or receive approval at separate times, combo site approvals are posted for each FWA/site, like the other sites on the study.