January 28, 2020 – PRMS
We wanted to provide an update on the Dana Farber / Harvard Cancer Center clinical trial support system. As you know, over the summer, we launched iRIS, an online submission and review system.
iRIS Readiness Center
iRIS is Now Live!
View the many articles and updates below, or visit the iRIS Wiki for additional resources.
Go-Live News/Announcements
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January 10, 2020 – PRMS
Please review the following tips and tricks that the iRIS team has gathered to help you to interact with the system better.
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January 10, 2020 – PRMS
The application for Secondary Use, Medical Record Review, and Non-Human Subject Research Determination have been simplified to include only the regulatory questions needed for such submissions and no longer require a...
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January 10, 2020 – PRMS
A new operational form, Sponsor- Investigator Add External Site Form, has been added to the General Forms section of the study management page. This form is to be utilized for Investigator-Sponsored, Multi-Center...
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January 10, 2020 – PRMS
In previous workflows for new trials and applicable amendment submissions, pharmacy and nursing had two separate reviews: Pre-SRC and Feasibility. These reviews have been combined.
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January 10, 2020 – PRMS
The process for attestation forms has been updated. Please note this is an operational form to assist the study team in tracking that COI is appropriately reported to the IRB per study, as applicable. All attestation...
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January 10, 2020 – PRMS
Per several requests, we have modified the way outcome letters and activation emails are handled.
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January 10, 2020 – PRMS
In an effort to increase transparency within iRIS, there has been an update to the Reviewer Details and Comments by Reviewers on Submissions. This report includes the review and sign-off only committee(s) your submission...
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November 20, 2019 – PRMS
The 2018 Common Rule requires use of a Single IRB (sIRB) for NIH studies as of January 2020; while we are rebuilding capacity internally, we would like to recommend an alternative to our clinical trialists that will save...
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November 20, 2019 – PRMS
The submission of completion of a study to IRB is now a separate submission from the continuing Review. A Study Completion Form has been created in iRIS. The purpose of the form, required documents and routing process...