Home Forums General Discussion Forum File documents with tracked changes? Reply To: File documents with tracked changes?

Qiutao Yu

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, 4 months ago by Qiutao Yu.