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March 21, 2023 at 10:42 am
#4985
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Participant
We file them (CSR/IB/MICF tracking versions) in Regulatory binder, but not repeatedly file into study eTMF as the 2 repositories working for different purposes/functions. In my view, Study eTMF cannot be exclusive for all regulatory required documents. For example, some compound level of documents generated from CMC/GMP.
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This reply was modified 1 year, 4 months ago by
Qiutao Yu.