Home Forums Where do I file…. ? Local Lab Documentation – ISF only? Reply To: Local Lab Documentation – ISF only?

#3842
Richard Golden
Participant

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