good clinical practice fda

Clinical Research IO Receives 21 CFR Part 11 and Annex 11 Attestation from Advarra

CRIO recently received attestation from Kinetiq (now Advarra) that our policies and procedures conform to the requirements of 21 CFR part 11 and Annex 11. Part 11 is the FDA’s requirement for use of electronic data in clinical trials, which is a part of Good Clinical Practice (GCP) and Good Documentation Practice (GDP). Annex 11...