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Purpose and Process of Clinical Audits

An audit of a clinical trial examines trial activities and documents to ensure compliance with regulations and that subjects' safety and data integrity are protected. The auditor verifies protocols are followed and results are reliable by visiting sites with monitors. Observations are documented in a report requiring sites to address issues through a corrective action plan tracked by the auditor.

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48 views4 pages

Purpose and Process of Clinical Audits

An audit of a clinical trial examines trial activities and documents to ensure compliance with regulations and that subjects' safety and data integrity are protected. The auditor verifies protocols are followed and results are reliable by visiting sites with monitors. Observations are documented in a report requiring sites to address issues through a corrective action plan tracked by the auditor.

Uploaded by

mrk_rlnd
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

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.

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