v. Inspection of investigator’s records and reports 21 CFR 812.145 [1]
The sponsor-investigator must allow FDA employees access to all records and reports at their request.
The sponsor-investigator must allow FDA employees access to all records and reports at their request.
Links:
[1] https://hso.research.uiowa.edu/v-inspection-investigator%E2%80%99s-records-and-reports-21-cfr-812145