Audits, inspections, and monitoring

Question 1

Audit

Answer 1

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 standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Conducted by Sponsor or CRO.

Question 2

Inspection

Answer 2

The 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 (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). Conducted by FDA.

Question 3

Monitoring

Answer 3

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). Conducted by Sponsor.

Question 4

goal of monitoring, auditing, or inspecting

Answer 4

to ensure the protection of human research subjects and data integrity.