See Also: Audit (of a clinical trial)(health)
Audit trial(health)
clinical trial(medicine)
Clinical trial(health)
phase III clinical trial(medicine)
phase II clinical trial(medicine)
clinical trial, phase I(medicine)
clinical trial, phase II(medicine)
clinical trial, phase IV(medicine)
clinical trial, phase III(medicine)

Audit (of a clinical trial) (health)


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, analysed and accurately reported according to the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirements.