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: IREx Study Manager
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: 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.
New Feature: Download a Report of Your Status Summary Tab
IREx Study Managers and Reviewing IRB Liaisons can download a CSV export of the Status Summary Tab for each study. On the Status Summary Tab, click Export Data > Export Status Summary Tab to download the data displayed on the Status Summary Tab.
New Feature: New IREx Study Manager Dashboard
IREx Study Managers have a new Study Manager Dashboard that gives an at-a-glance summary of their studies in IREx. For each study, the dashboard shows Study Managers how many participating sites have 1) registered, 2) completed each of the required agreements, 3) indicated reliance, 4) completed all local considerations (if applicable), and 5) received approval for the current version. The dashboard is color-coded, and each counter will turn green when all the participating sites listed on the study have completed that step.
New Feature: See Who Has Access to Your Study in IREx
Reviewing IRB Liaisons and IREx Study Managers can now view or download a list of Participating Site Personnel that have access to their studies in IREx. On the study page, click “Participating Personnel” above the study title to view the list.
New Feature: Manually Notify HRRPs and Investigators About Your Study in IREx
IREx now allows Reviewing IRB Liaisons and IREx Study Managers to manually notify sites about their study in IREx instead of automatically emailing sites as soon as they are added to a study. Now sites can be notified at different times if they are being onboarded at different times.
When an IREx Study Managers lists a site on a study, they will enter a PI name and email. The site will appear on the Status Summary Tab. Click the “Notify HRPP” button to notify the site HRPP (and the PI identified) of the study in IREx. This does not give the PI access to IREx. The purpose of this email is to connect the investigator to their local HRPP.
New Feature: Introducing: The IREx Study Manager
Lead Study Teams and Coordinating Center Staff will now be called “IREx Study Managers”. IREx Study Managers play a vital role in tracking Participating Sites’ as they navigate the reliance process. The new IREx Study Manager Checklist outlines how Study Managers can manage their Participating Sites, manually notify site HRPPs and PIs of the study in IREx, export Local Considerations for submission to the sIRB and upload Participating Sites approval documents to IREx. IREx Study Managers should be sure to talk to the Reviewing IRBs about how they plan to leverage this role to support the study in IREx.
Bug Fixes – July 21, 2018
| Fixed: The Status Summary Tab has been updated to better distinguish component site reliance progress as distinct from the FWA holder. |
| Fixed: IREx has been updated to allow the Lead Study Team to export local context on studies where there are no coordinating center staff listed. |
Update: Status Summary Now Includes Dates of HRPP Activity
To better inform the Reviewing IRB and Coordinating Center / Lead Study Team, the Status Summary Tab now tracks when Participating Site HRPPs 1) are “contacted” about a study in IREx, 2) “start” the reliance process by accessing the study in IREx and, 3) “complete” their cede decision in IREx.