aligned to the drug development program so that
the audits are placed in accordance with the com-
plexity and the importance of the clinical trials for a
regulatory submission. Application of risk assess-
ment and management methods may be helpful to
identify high-risk areas in the company’s clinical
research environment.
For example, first-in-man studies and pivotal
trials are more likely to be audited than phase IV
trials, and external providers selected for the first
time who are responsible for key areas in clinical
trials should be audited with a higher priority than
CROs with a long history and reliable perfor-
mance.
Audit plan
For each individual audit, it is useful to prepare
an audit plan to provide the auditee with an over-
view on the audit components and the conduct of
the audit. An audit plan may also be useful as a
basis for agreement between the sponsor, the
(external) QA auditor and the audit team. It is
common practice in clinical research to draw up
an audit plan and distribute this information prior
to the audit.
ISO 19011:2002 (2002) suggests including the
following information in the audit plan:
Type and scope of the audit; organizational and
functional units and processes to be audited.
Audit objectives and reason for conducting the
audit, if appropriate.
Audit criteria and reference documents.
Identification of the client/sponsor and trial
protocol.
Date(s) and location(s) of audit activities at the
site together with expected time and duration of
activities, including any audit-related meetings.
Names, roles and responsibilities of the audit
team members and technical experts accompa-
nying the audit team, if appropriate.
The following details may also be addressed in the
audit plan, as required:Language in which the audit will be conducted
and the audit report will be written where this is
different from the language of the auditor and/or
the auditee.Structure of the audit report.Travel arrangement for auditors, where required,
and logistic arrangements at facilities at the
site (e.g. pharmacy, packaging area, laboratory,
etc.).Confidentiality agreements.Follow-up activities to the audit.Audit-related correspondence
For announced audits, it is good business practice
to inform the auditee in writing of the planned
audit and to agree on a mutually feasible audit
date. Once the audit is scheduled, the audit
plan should be sent with a cover letter to the
auditee, audit team members, technical experts
(if involved) and the client/sponsor (in case of
third party audits).
After the audit, a letter to the auditee should
confirm that an audit has taken place and to thank
the site staff for their availability and assistance
during the audit. The letter should not include
deficiencies or observations made during the
audit; however, follow-up procedures can be out-
lined. For unannounced audits, only the audit con-
firmation letter is mandatory.
QA should keep records of all correspondence
with the auditee and should check during the audit
that the announcement letter and audit plan were
received at the auditee’s site.Audit team
Prior to the audit, the audit team needs to be estab-
lished if the audit is conducted by more than one166 CH13 QUALITY ASSURANCE, QUALITY CONTROL AND AUDIT