The benchmark activity detailed in this article demonstrates the degree of harmonization in the general performance and reporting
of investigator site audits within the pharmaceutical industry. The vast majority of respondents surveyed confirmed that the
audit teams operate to globally standardized processes. Most companies classify the audit findings in terms of severity and
they categorize them with respect to impact on specific processes. All companies expect responses to critical and major findings.
Seventy-five percent of the companies who responded conduct trend analyses, but their target audience and further utilization
vary among the companies. The greatest variation occurred in the mechanism for ensuring that audit findings are considered
in the overall process improvement cycle.
In summary, this benchmarking exercise provides assurance that the pharmaceutical industry has made major steps toward a common
approach to investigator site audits. This leads to the benefit of individual sites and studies and to the overall process
of clinical development.
CQA survey
In order to ascertain prevailing practices in the industry, a survey was conducted in the area of clinical quality assurance
(CQA). CQA was defined as the corporate department or function with the main responsibility of assessing and supporting compliance
of clinical development projects and systems with GCP standards. This specific survey was conducted in order to obtain benchmark
data on the consistency of audit practices and the impact of audit findings originating from investigator site audits.
Survey method
A questionnaire was developed by a working group within the German Association of Research-Based Pharmaceutical Companies
(VFA) Clinical Research/Quality Assurance Committee. This questionnaire was distributed in mid-February 2005 to 38 global
companies in order to collect the benchmark data via the Internet. The creation and online submission of the survey and capture
of feedback was simplified by the use of Zoomerang online survey products. Feedback was received from 29 companies (14 European,
10 American, four Japanese, and one Australian), which corresponds to an additional response rate of 81%. All responses were
valid and used in the overall evaluation of the results. Global QA Heads of GCP or their delegates completed the questionnaire.
The results represent a global perspective on general performance and reporting of investigator site audits.
It should be noted that four of the companies originally contacted merged during the course of the survey. Out of the four
companies, two provided a consolidated response and two did not.
Results
The following results are based on feedback received from the 29 companies. The survey collated information on the following
areas:
- standards for investigator site audits
- categorization of audit findings
- classification of audit findings
- reporting of audit findings
- distribution of draft and final audit reports
- responding to audit reports/findings
- trend analysis of audit findings.
Standards for audits
Global Documents/Tools Within Companies
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More than 80% of the companies have a globally standardized audit process in place—i.e., all auditors worldwide are working
according to the same audit SOP, audit standard, checklist/worksheets, tools, etc. Global documents and tools in place within
the companies are shown in Figure 1.
