iRIS serves oncology trials at Beth Israel Deaconess Medical CenterBoston Children's HospitalBrigham and Women's HospitalDana-Farber Cancer InstituteMassachusetts General Hospital, and other affiliated institutions. 

Visit the iRIS Wiki for more details.
ANNOUNCEMENT
Dear DF/HCC Research Community, 

iRIS has undergone a few minor updates today, Friday, July 30th. Please review the summary of changes and friendly reminders below.
The Details
What is changing?

  • When selecting the appropriate new study application, you will notice two changes: 
  • A prefix of “DFHCC OHRS Application…” has been added to the pre-existing applications. This will help differentiate between new applications that will be added to the system such as the one below.
  • A new application will appear titled “Basic Research (DFCI Only) Biological Registration.” This application is for DFCI Only and this option should be selected for submitting Non-Clinical Biological Registration forms. This form will only be routed to the DFCI Biohazard Control Committee (BCC) for review and approval.
  • Estimating IRB Review Dates
  • The “Estimated IRB Review Dates for submissions routed to SRC” has been retitled to “Estimated IRB Review Dates for New Protocols.”
  • A similar report titled “Estimated IRB Review Dates – Industry Phase I NPs ONLY” has been created. The new Phase 1 timeframe reflects the more limited scientific revisions allowed in industry sponsored trials, and current efforts to activate efficiently for participation in early phase trials.
  • The IRB Response/Correction forms have a new question for study teams to indicate if any new information was included in the response that was not specifically requested as a condition. This is meant to be used for changes such as additional risks added to the consent or minor consent wording changes. Please note that if study teams make changes beyond those requested in the IRB conditions, this may affect whether the protocol needs to return to the IRB for an additional review. Research teams should not make changes that affect other review committees or would impact feasibility or SRC. If you have questions about what minor changes may be possible to implement, please contact OHRS.
  • Study Contacts will now receive an email notification when a committee enters a “Withdrawn” outcome for amendments and New Project Applications.
  • Amendment form updates (including sIRB and CTEP)
  • The description of a “Therapy” change has been updated. There are no changes to what is considered a Therapy change; however, the language has been clarified to better explain the scenarios where Therapy must be selected. 
  • Closure date no longer required when changing the status to closed.
  • Other minor language changes.
  • MGH Waltham is no longer a selectable satellite site.

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
Erica Woulf
Senior Director for Research Informatics Operations,
Dana-Farber/Harvard Cancer Center