Reply To: Where to File IRB or IEC Continuing Review Approval

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July 24, 2020 at 5:19 pm #3701
Todd Tullis
Participant

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