Monitoring and Audits
The International Council of Harmonization—Good Clinical Practice (ICH-GCP) defines monitoring as "an act of overseeing the progress of a clinical trial, so as to ensure that the trial is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s)". It is a quality control tool done at a regular frequency determined by a predefined plan.
An audit, on the other hand, is "a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's SOPs, GCP, and the applicable regulatory requirement(s)".
Institutional Review Boards, Sponsors, federal agencies, and compliance monitors may routinely select, at random, studies to audit. Audits also may be initiated due to a complaint, non-compliance, question pertaining to the qualifications of investigators as well as due to observations made by an FDA representative during an inspection.