Where to File IRB or IEC Continuing Review Approval

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    • #3698
      Janna Gonzalez

      Good morning All,

      where do I file a IRB Continuing Reviewe Approval Submission Letter, For PI & Study Coordinator & Site?


    • #3701
      Todd Tullis

      Hi Janna there are two primary TMF artifacts related to IRB Submissions:
      04.01.01 IRB or IEC Submission
      04.01.02 IRB or IEC Approval

      Essentially, any cover letters or submission confirmations go into 04.01.01; anything you get back from IRB regarding their decision (or requests for more information) goes in 04.01.02

    • #3705
      Janna Gonzalez

      Thank you!

      I have a Cover letters only responses to IRB or IEC from Site. I filed it in o4.01.01.

      I have a IRB or IEC Continuing Review of Trial Cover letter only. I filed it on 04.01.02.

      Is this correct?
      thank you,


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