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The concept of quality in clinical research

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Abstract

Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000.

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References

  1. Magyar Szabványügyi Testület (2001) MSZ EN ISO 9000:2001.

  2. ICH Guideline for Good Clinical Practice Step, Consolidated Guideline 1.5.96, including post Step 4 errata September 1997.

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Authors and Affiliations

  1. AstraZeneca Pharma Poland Sp. z o.o. C, ul. Domaniewska 41 Neptun, 02-672, Warsaw, Poland

    Dorota Śwituła M.D.

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  1. Dorota Śwituła M.D.
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Correspondence to Dorota Śwituła M.D..

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Śwituła, D. The concept of quality in clinical research. SCI ENG ETHICS 12, 147–156 (2006). https://doi.org/10.1007/s11948-006-0015-x

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  • DOI: https://doi.org/10.1007/s11948-006-0015-x

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