auditor. The lead auditor must be nominated and
responsibilities for the individual team members
should be clearly assigned, considering compe-
tence and expertise. The same is true if technical
experts (internal or external) are involved in the
audit. Technical experts should be independent of
the auditee and activities to be audited. In any case,
the responsibility for the audit will rest with the
lead auditor and the audit team.
Audit tools
Recording audit observations is an essential part of
the audit to enable the auditor to prepare detailed,
accurate and complete audit reports which are
based on factual observations. Checklists, audit
questionnaires and sampling plans are useful
tools and should be prepared prior to the audit.
Generic checklists may be a good start and can
be refined as required for each audit to account for
trial-specific issues. Source data verification
(SDV) templates are always trial-specific as each
clinical trial is unique. Although checklists and
questionnaires are very useful to record audit
observations, they should never restrict the extent
and scope of audit activities and allow for flexibil-
ity during the audit.
Opening meeting
An opening meeting should be held with the audi-
tee and his/her management, if appropriate, and
those responsible for the functions and processes to
be audited, in order to confirm the audit plan and
the sequence of reviews and topics and to present
the audit procedures. The purpose of the meeting is
also to confirm that documents to be audited and
individuals to be interviewed are available.
Communication during the audit
Depending on the duration of the audit, interim
meetings with the auditees may be necessary to
discuss interim results, ideally at the closure of
each audit day. For the audit team, it is very useful
to confer periodically to exchange audit observa-
tions and information to assess the audit progress.
The lead auditor is responsible for communication
with the auditee.
The auditee and/or the sponsor should be
informed without delay in case serious deficien-
cies are uncovered which may pose a high risk
for either trial participants or the clinical data.
Likewise, if the audit scope cannot be covered
during the scheduled time for the audit, the
auditee and/or the sponsor must be notified and
appropriate action should be determined (e.g.
extension of the audit time or modification of
the audit plan, etc.).
Audit notes, audit evidence, audit
findings and audit conclusions
Auditnotesare indispensable to allow QA auditors
to write an accurate report after the audit. Detailed
notes allow the auditor to prepare a meaningful
audit report which is based on verified observa-
tions. All information collected during an audit is
considered auditevidence. Information sources in
an audit are, for example, document review, inter-
views and observation of activities. If applicable,
sampling techniques may be applied, for example
for SDV and verification of information in tables
and listings. Audit observations are only consid-
ered auditfindingsif it is determined after compar-
ison with audit criteria that these are not or
insufficiently fulfilled. And finally, auditconclu-
sionscan be drawn to assess whether the audit
findings impact the validity of the clinical data
and the safety of the trial subjects.
Closing meeting
It is good auditing practice at the termination of the
audit to conduct a closing meeting with the auditee
to present the audit findings and conclusions. This
is also the last opportunity for the auditee to clarify
potential misunderstandings by the audit team and
to provide requested documentation. The lead
auditor should chair this meeting and, if applicable,
address follow-up activities.
13.5 AUDITS FROM A TO Z 167