Categorization of findings 
Main Categories Used for Audit Findings
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All participating companies, with the exception of one, assign audit findings to process related categories, such as "informed
consent," "study protocol compliance," or "safety reporting." Most companies use similar categories for the critical processes
that are subject to an audit (see Figure 2). All companies utilizing such categorizations use the categories "safety reporting"
and "informed consent." Approximately 90% use the categories "IRB/IEC," "source documents," "drug supply handling," and "protocol
compliance," and approximately 80% use the categories "essential documents," "study personnel and agreements," "monitoring,"
and "data accuracy/SDV." Each of the 14 categories provided in the survey is used by at least 66% of the companies. Additional
categories not specifically listed in the questionnaire—such as "trial management," "training," and "computer validation"—are
also used by some companies.
Classification of findings Almost 80% of the companies evaluate the significance of each single audit finding and state this in the audit report. The
most frequent classifications used are "critical," "major," and "minor." In addition, one fourth of the companies have a system or rule to evaluate the significance of each category, stating the
overall evaluation of all findings related to each one (e.g., informed consent). About 50% of the companies classify the overall outcome of site audits. Half of them use predefined classifications, while
the other half provide narratives. If predefined classifications are used, they are similar to those used for single audit
findings. Reporting of findings About 70% of the companies have a multistep reporting process implemented (e.g., draft/final reports); the other companies
have a single-step reporting process in place. For approximately 85% of the companies, the audit report contains an executive summary, which is normally distributed as part
of the full audit report. All companies, with the exception of one, apply QC measures to the audit report generation process—most after peer reviews,
conducted by either an auditor colleague or line manager within QA. Draft and final report Around 90% of the companies make the draft and/or the final audit report available to the auditees. Two companies neither
provide the draft nor the final report to the auditees. About 30% of the companies do not provide management with the draft
report, but 97% do provide them with the final report. Only one company doesn't make the draft or the final audit report available
to management. Approximately 50% of the companies send the audit report to other affected functions (e.g., regulatory affairs, regional organization
members, training, purchasing, etc.), but from the available information, no pattern could be identified. Time frame for reporting 
Length of Time to Report Audits
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The defined time frame between the conduct of the audit and the release of the report varies between 5 and 40 working days
(median of 15 working days, mean of 16.6 working days). Thirty-four percent need to issue the report within two weeks, 59%
within three weeks, and 76% within four weeks. Ten percent of the companies need to issue the audit report after more than
five weeks. Two companies have no defined timeline for the availability of the audit report (see Figure 3).
Critical audit findings Expedited Reporting. Two-thirds of the companies report critical findings in an expedited manner. Some companies stated that critical findings
have to be reported to QA senior management and/or appropriate clinical management either immediately (i.e., during the audit
conduct) or within up to 5 working days by phone, email, or meeting. Clinical study reports. About 60% of the companies report critical audit findings and/or corresponding corrective actions in their final clinical
study report. IRBs/IECs and agencies. Only 17% of the companies report critical audit findings and/or corresponding corrective actions directly to IRBs/IECs and
agencies. Recommendations/requests for corrective actions. Two-thirds of the audit reports contain recommendations or requests for corrective actions for either critical findings or
major findings. About half of the audit reports contain recommendations or requests for corrective actions for minor findings.
Fourteen percent of the companies do not give recommendations or requests of this kind at all in their audit reports. Responding to reports/findings All companies, except one, request responses to each of their audit reports. This company, though, expects responses in the
case of critical or major findings as well. In terms of addressing individual findings, all companies expect critical and
major findings to be individually addressed. Still, 83% of the companies expect a response to minor findings. Responsibility for replying. In about 60% of the companies the study manager and the monitor are both responsible for replying to audit findings; in six
of the companies, this responsibility lies with either one. Thus, in 80% of the companies at least one of these two individuals
is responsible for replying. In half of the companies, line management is involved in providing responses: For eight companies, in addition to the monitor
or the study manager, line management is responsible for replying. In six companies, only line management is responsible for
addressing audit findings.
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