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

[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