PURPOSE OF AN AUDIT

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, sponsors standard operating procedures (SOPs),
Good Clinical Practice (GCP), and the applicable regulatory
requirement(s)
(ICH GCP Guidelines, 1996)

 The primary objective of an audit is to ensure that

the safety and rights of the subjects are respected
and that the integrity of the data from the trial can
be assured.
It is expected from the sponsors to implement
systems with procedures that is in accordance with
the regulatory requirements, GCP and the study
protocol.

ACTIVITIES DURING THE AUDIT

The auditor, accompanied by the study monitor, will
visit the site in order to verify and ensure that the
study protocols are properly followed and to
establish whether the results generated are reliable
to assess any regulatory risks.

 A detailed audit report is then written together with

the observations made during the audit.
Subsequently, it is required from the site to develop
a corrective and preventative action plan (CAPA)
which is tracked by the auditor and the
implementation of the actions is the responsibility of
the site being audited.