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...
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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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...
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November 20, 2019 – PRMS
Previous communications instructed study teams to upload in iRIS the consent form at time of initial protocol submission at least ten days prior to the IRB meeting. However, after some experience with this process, we...
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November 20, 2019 – PRMS
The Declaration of Dose Form has been renamed to Dose/Cohort Open/Closure Form. There are several enhancements to the form that will now make it easier to open or close a cohort within a Phase I study.
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November 20, 2019 – PRMS
Two new resources are now available on the wiki. The Defining Submission History guide provides an in-depth look into the submission history tab on the protocol dashboard. The Guide on who to Contact should be used to...
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November 20, 2019 – PRMS
It is important to follow the proper steps in iRIS to ensure the sub-site invitations are being properly routed and accepted within iRIS.
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November 20, 2019 – PRMS
Any amendment submitted after November 20th, 2019, requiring Sub-site feasibility, will now be routed to the Sub-site feasibility committees without the need of the Sub-site amendment form. This form is no longer...
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November 20, 2019 – PRMS
For New Cell Therapy Trials submitted in iRIS, finalized Product and Apheresis Manuals must be included along with the final protocol and pharmacy manual (if applicable) at initial submission. The Cell Therapy reviewers...
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November 20, 2019 – PRMS
Activation emails are still not being sent to Sub-site study contacts. Until a solution is developed, it is the responsibility of the Lead Site to forward the activation emails to the Sub-site. Sub-sites should also...
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November 20, 2019 – PRMS
Tips on work instructions, IRB exempt trials, and continuing reviews