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July 24, 2020 at 5:19 pm
#3701
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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