Quality management for the collection of biological samples in multicentre studies

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 sy...

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Bibliographic Details
Published in:European journal of epidemiology 2010-09, Vol.25 (9), p.607-617
Main Authors: Peplies, J, Fraterman, A, Scott, R, Russo, P, Bammann, K
Format: Article
Language:English
Subjects:
Biological and medical sciences
Biological samples
Biological specimen bank
Blood
Blood specimen collection
Cardiology
cohort studies
Collection acquisitions
Desiccation
Documentation
Environmental conditions
Epidemiology
General aspects
Humans
Infectious Diseases
Medical research
Medical sciences
Medicine
Medicine & Public Health
METHODS
Miscellaneous
Multicenter studies
Multicenter Studies as Topic - methods
Multicenter Studies as Topic - standards
Multicentre study
Oncology
Public Health
Public health. Hygiene
Public health. Hygiene-occupational medicine
Quality assurance
Quality Control
Quality management
Research methodology
Response rates
Saliva
Sample database
Samples
Specimen Handling - methods
Specimen Handling - standards
surveys
Urine
Urine specimen collection
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Summary: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.
ISSN:0393-2990
1573-7284
DOI:10.1007/s10654-010-9481-1