Audits and Inspections of Clinical Investigations of Devices

Question 1

Audit

Answer 1

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 standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s)

Question 2

Monitoring

Answer 2

the act of overseeing the progress of a clinical trial, and of ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s)

Question 3

Inspection

Answer 3

act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO) facilities, or at other establishments deemed appropriate by the regulatory authority(ies)