Investigator Site Audit Performance - Applied Clinical Trials

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Investigator Site Audit Performance
CQA benchmark survey finds companies use a similar method to conduct and report audits.
Jun 1, 2006
By: Ursula Streicher-Saied, Heiner Gertzen, Arthur Hecht, Bettina Nusser, Per-Holger Sanden, Dorette Schrag-Floß
Applied Clinical Trials

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For this survey we obtained a remarkably high response rate of 81%, and nearly all responses could be analyzed without further queries. We identified a relatively uniform process of audit conduct and reporting. Despite some common trends, impact and use of audit findings showed more variability. This variation may reflect differences in the organization, standards, and operations of the companies.

Acknowledgement

The authors would like to express their thanks to all participating companies for their valuable input, which made this analysis and publication possible.

Ursula Streicher-Saied,* PhD, is head of global quality management for Bayer HealthCare AG, Germany, email: ursula.streicher-saied@bayerhealthcare.com
Heiner Gertzen, PhD, is head of clinical quality and compliance, Europe, for sanofi-aventis, France. Arthur Hecht, Dipl.-Ing, is head of clinical quality assurance for Boehringer Ingelheim Pharma GmbH & Co. KG, Germany. Bettina Nusser is senior manager of clinical quality management, MSD, Germany. Dorette Schrag-Floβ is head of global clinical quality assurance, ZLB Behring GmbH, Germany. Per-Holger Sanden is head of clinical quality assurance, Merck KGaA, Darmstadt, Germany.

*To whom all correspondence should be sent.

References

1. H. Gertzen, A. Hecht, E.B. Ansmann, "Clinical Quality Assurance Benchmarking," Applied Clinical Trials, 70–82 (June 2004).

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Source: Applied Clinical Trials, 6/1/2006
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