A systematic, disciplined, independent and documented process for obtaining audit evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled. GVP Annex I - Definitions (Rev 5)

A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract research organisation (CRO)) or institution to determine whether the evaluated trial-related activities were conducted and the data were recorded, analysed and accurately reported according to the protocol, applicable standard operating procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirement(s). ICH E6(R3)