v. Inspection of investigator’s records and reports 21 CFR 312.68

The sponsor-investigator must allow FDA employees access to all records and reports at their request.  An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to 21 CFR 312.62 [21 CFR 312.68].  The investigator is not required to divulge participant names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.