Tracked changes version(IRB approved) versus clean version (IRB approved)

[Amrita Bains]

Please confirm if both tracked changes version (IRB approved) has to be filed in addition to the clean version (IRB approved) in the eTMF. Thank you.

[Richard Golden]

Speaking only to my own experience, track changes docs are uploaded only if they were part of a specific regulatory or IRB submission package (and especially if the RA or IRB requested the track changes docs). Of course, a sponsor can use their own discretion beyond those two circumstances.

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