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Quality management for the collection of biological samples in multicentre studies

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Abstract

Large scale international multicentre studies require sophisticated quality management for the collection, processing and logistics of biological samples to ensure a maximum degree of standardisation across different environmental conditions and settings. This paper describes a quality management system for the collection of biological samples (QMS-BS) which was applied during IDEFICS, a large European multicentre study. The application was evaluated by several criteria like response rates for the different types of biological samples, measures of sample quality, compliance with the QMS-BS and efficiency of the document and sample control and of the quality assurance system. Response rates varied from 56.6% for venous blood collection to 90.1% for saliva collection. All sample types were associated with problems of sample quality (e.g. haemolysis of blood samples, lack of cooling for urine samples or desiccation of saliva samples). Overall compliance with the QMS-BS was good, with some exceptions mainly related to sample control. In conclusion the QMS-BS is a valuable tool for the management of biological sample collection in epidemiological multicentre studies.

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Abbreviations

ADR:

Agreement concerning the International Carriage of Dangerous Goods by Road

DNA:

Deoxyribonucleic acid

FA:

Fatty acid

GEP:

Good epidemiological practice

IATA:

International air transport association

ICAO:

International civil aviation organization

IDEFICS:

Identification and prevention of dietary—and lifestyle—induced health Effects in Children and infantS

IEA:

International epidemiological association

INRS:

Institut National de Recherche et de Securite

ISO:

International organization for standardization

QMS:

Quality management system

QMS-BS:

Quality management system for biological samples

RFID:

Radio-frequency identification

RNA:

Ribonucleic acid

SOP:

Standard operation procedure

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Acknowledgments

This work was done as part of the IDEFICS Study (www.idefics.eu). We gratefully acknowledge the financial support of the European Community within the Sixth RTD Framework Programme Contract No. 016181 (FOOD). The authors are indebted to the IDEFICS survey centres for their work in gathering the data. We also thank Wolfgang Ahrens for helpful suggestions on the manuscript.

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Authors and Affiliations

  1. Bremen Institute for Prevention Research and Social Medicine, University of Bremen, Bremen, Germany

    J. Peplies & K. Bammann

  2. Laboratoriumsmedizin Dr. Eberhard und Partner, Dortmund, Germany

    A. Fraterman

  3. MRC Epidemiology Unit, Institute of Metabolic Science, Cambridege, England

    R. Scott

  4. Institute of Food Sciences, CNR, Avellino, Italy

    P. Russo

Authors
  1. J. Peplies
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  2. A. Fraterman
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  3. R. Scott
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  4. P. Russo
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  5. K. Bammann
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Correspondence to J. Peplies.

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This article is written on behalf of the IDEFICS consortium.

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Peplies, J., Fraterman, A., Scott, R. et al. Quality management for the collection of biological samples in multicentre studies. Eur J Epidemiol 25, 607–617 (2010). https://doi.org/10.1007/s10654-010-9481-1

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