iRIS Readiness Center

UPCOMING OFFICE HOURS Q&A SESSIONS

Third session: "Submission Routing" - Click here for more information


View the many articles and updates below, or visit the iRIS Wiki for additional resources.

Go-Live News/Announcements

  • 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...

  • 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.

  • 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...

  • 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.

  • 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...

  • 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...

  • 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...

  • November 20, 2019 – PRMS

    Tips on work instructions, IRB exempt trials, and continuing reviews

  • October 22, 2019 – PRMS

    Subsites are currently not receiving activation emails for amendments. A solution for this is in development. For now, please check OncPro to see if the submission is active.

  • October 21, 2019 – PRMS

    All communication emails relating to a specific trial will be sent to the staff listed in iRIS under Study Contact. At time of new submission, the Overall PI will default to be listed as a study contact. If the PI has...

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