iRIS Navigations for Multiple Submissions - Now available for all phases of Therapeutic Trials

DF/HCC Research Teams and iRIS Users,

We are excited to let you know that we are now able to offer iRIS Navigator support for multiple, time-sensitive amendments on all therapeutic protocols, regardless of phase.

Research teams who have utilized the iRIS Navigator service have shared a lot of helpful and positive feedback. We look forward to helping more teams with the expansion of this service.

What types of requests can the iRIS Navigators help with?

If the initial submission or an amendment is pending approval in iRIS, please contact the iRIS Navigators to request guidance on:

• Bundling a time-sensitive new amendment into the existing amendment or initial submission
• Submitting a second amendment in parallel
• Assistance with pending initial submissions where a newly received amendment is required to activate

Important!You must request navigation assistance before submitting more than one amendment at a time.

How to I initiate a request to the iRIS Navigators?

Please email DFHCCiRISNavigator@dfci.harvard.edu with a brief description of the request, the protocol number and reference number of the existing submission. Please also include in the email a copy of any new or revised documents that need to be submitted.

Note: If you don’t yet have all the documents needed for the next submission, or it is not time sensitive, we ask that you wait until the current submission has activated to submit the next amendment.

It is not necessary to contact the iRIS Navigator if...

As a reminder, amendments can be submitted in parallel with any of the following; no approval or navigation support is required!

• Continuing Review/Progress Report
• Administrative Modification
• Dose/Cohort Open/Closure Form
• Events
• Sponsor-Investigator Add/Open/Complete External Site

Who do I contact for general iRIS questions or troubleshooting?

iRIS users should continue to utilize the iRIS WIKI resources, local superusers, institutional clinical trials offices, and the Guide on Who to Contact found on the WIKI front page. Please do not contact the iRIS Navigators with general questions or requests for technical support.

If you have any questions about this announcement, please reach out to DFHCCiRISNavigator@dfci.harvard.edu. We’re happy to help!

Sincerely,