iRIS has undergone a few important updates today, Tuesday, May 25th. Please review the summary of changes and friendly reminders below. The Wiki will be updated accordingly.
iRIS serves oncology trials at Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, and other affiliated institutions.
Pharmacy Order Set Updates for Phase I and Phase I/II trials only
New Process
Only a single dose level will be built and validated in your institute’s order set system (e.g., Beacon, OMS, etc.). This may or may not match what first opens at activation. Note: All cohorts and dose levels will still be built in OnCore.
Additional order sets for dose levels and cohorts will be built as needed based on Amendments and Dose/Cohort submissions that request a dose level be built and opened.
iRIS Changes
For New Protocols activated as Open to Accrual, Research teams will need to submit a separate Dose/Cohort form once the active dose levels confirmed. Note: The New Protocol Operational Readiness Checklist has been updated to remind study teams to submit the form.
For New Protocols activated as On Hold, Research teams will need to submit an amendment to change the enrollment status to Open to Accrual and open specific dose levels.
Drug Section:
A new “FDA Status” question was added that will be required for some drugs added to studies going forward.
Wiki Friendly Reminders:
The applicable Wiki documents have been updated with all changes accompanying this release.
The iRIS Updates section, found on the iRIS Wiki landing page, provides a table of all iRIS updates and the date of their release.
Oncology trials in Boston are a collaborative effort involving many from many institutions. iRIS represents an opportunity to streamline all of the processes involved, and move trials from submission to activation, and to our patients, more quickly. Please take advantage of all of the provided information and resources to help us make this system as efficient to use as possible.
Sincerely,
Jeffrey Meyerhardt, MD, MPH
Associate Director for Clinical Trials,
Dana-Farber/Harvard Cancer Center
Drew Memmott
Associate Director for Administration,
Dana-Farber/Harvard Cancer Center
Erica Woulf
Senior Director for Research Informatics Operations,
