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November 11, 2020 at 3:33 pm #3842
We have included local lab information in the TMF at the site or country level – normal ranges, accreditation certificates, along with the central lab information at the study level.
I understand those who express concern about “duplicating” the ISF in the TMF but my understanding is that an inspector may not be satisfied with a note to file repeatedly pointing to the ISF – not sure there is a “correct” answer
- This reply was modified 2 years, 6 months ago by Richard Golden.