Two new fields were added to the Status Summary Export – “Date Submitted” to the sIRB and “Date Reviewed” by the sIRB. The Export already includes “Date Approved” by the sIRB. These additional fields can be used by Study Managers as a flag/reminder that a site has been submitted for review to the sIRB. The sIRB or SM can enter dates of sIRB submission and review in the “site approvals” dialogue.
Category Archives: FRL
Updated Feature: Local Considerations Complete Notification Now Includes Outstanding Steps
In May we added “Complete Agreements” to the Relying HRPP Getting Started checklist. This feature allows sites to document and complete local considerations while their legal counsel is reviewing and executing any outstanding agreements, if needed. Sites are not allowed to document reliance or cede review until the agreements are complete, but, if a site completes local considerations before their agreements are complete, we now include in the email any outstanding steps that should be completed before the site is submitted to the sIRB for review, such as “Complete Agreements” or “Cede Review”.
Bug Fixes – July 29, 2019
| Fixed: IREx “Users” can now view studies where a component of their FWA is participating. |
| Fixed: The “Resources” link in the Study Manager welcome email was updated. |
| Fixed: The Local Considerations export now labels the component site folder using the FWA “short name” and the component site “short name” (e.g., North Univ Med Ctr– North Childrens Hosp”). |
New Feature: Capture Site-specific Comments
Reviewing IRB Liaisons and Study Managers can now include site-specific comments on the Status Summary tab in IREx. Comments are only visible to the Reviewing IRB Liaisons and Study Managers on a study. No notifications are generated by these comments. Any information that helps keep track of site’s progress can be logged, such as:
- the last time you contacted a site
- when you sent reliance instructions
- unique workflow challenges or alternatives for a site
- status updates from a PI or a site’s HRPP
- reason a site’s local review might be delayed
New Feature: Indicate “No Further Review Required” for Qualifying Studies
In line with the revised Common Rule, IREx now allows sIRBs to indicate “No Further Review Required” and NOT enter an expiration date for studies that no longer require continuing review (more here). For studies where this feature is used, sites will no longer have an expiration date listed in IREx and the IREx approval notifications will direct site investigators to refer to the approval letter from the sIRB and their local HRPP for ongoing reporting requirements.
Bug Fixes – June 28, 2019
| Fixed: IREx behaved erratically when users accessed it via Internet Explorer (IE), so the platform was updated to more compatible with IE. |
| Fixed: When uploading a relying site’s approvals, dates of submission, review and approval are required. IREx was requiring the dates, but not telling Study Managers which sites were missing dates. |
New Feature: Added Study Short Name to Email Subject
IREx now includes a study short name in the subject line of each email to allow users to sort, group and prioritize their emails from IREx.
New Feature: Include date local considerations surveys were “Updated”
Sometimes Study Managers (SMs) or sIRBs need PSites to make changes to the local considerations they provided in IREx. Before receiving sIRB approval for a study, PSite HRPPs and PIs can make these edits to the Human Research Protection (HRP) and PI surveys (Note: PIs can only make edits before their HRPP validates their answers). IREx will now track when updates were made by the PI or HRPP and include this date on the Status Summary tab so Study Managers can see when the information was last updated.
System Enhancements – May 31, 2019
| Enhanced: IREx requires a determination letter and consent forms (if applicable) be uploaded as part of the Relying Site Approvals. However, IREx also allows for “Other” documents. Study Managers (SMs) can add a label to name the type of document they are uploading. Customizing the types of documents allows for greater specificity and helps better group the documents. |
| Enhanced: When a PSite finishes documenting their local considerations for a study, IREx automatically notifies the SM and sIRB. We updated the text of this email to include language that the SM should pre-screen the information provided in the surveys to ensure the right type of information is provided. If any changes are needed, they can request the PSite edit the local considerations in IREx. The SM and sIRB will also be notified when updates are made. |
Bug Fixes – May 31, 2019
| Fixed: The load time was improved for studies. |
| Fixed: The PDF for Institutional Profiles generated too small when large amounts of text were entered for a question. It now generates in the correct format for printing. |