iRIS Update Center

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

System News/Announcements

  • 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...

  • 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.

  • 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...

  • January 10, 2020 – PRMS

    Per several requests, we have modified the way outcome letters and activation emails are handled.

  • 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...

  • 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...

  • 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...

  • 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...

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