# of Samples Required after transition to CTR

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October 15, 2024

# of Samples Required after transition to CTR

When study was under CTD, we were pulling 2 labeled FG samples per Annex 13. Now that we’ve transitioned to CTR and are under the guidance of Annex 6- it’s not clear how many samples are needed and not clear if we need to now have 1 of the booklet labels also as a retain. For labeled FG- how many samples/retains are you pulling and are you also pulling a retain of the label?

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