Reply To: File documents with tracked changes?

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#4985
Qiutao Yu
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.

  • This reply was modified 1 year, 1 month ago by Qiutao Yu.