The Virtual Central Laboratory approach for the retrieval and management of clinical laboratory data for clinical studies

Citation
R. Scholten et Jhm. Dijkman, The Virtual Central Laboratory approach for the retrieval and management of clinical laboratory data for clinical studies, ACCRED Q A, 4(9-10), 1999, pp. 434-435
Categorie Soggetti
Spectroscopy /Instrumentation/Analytical Sciences
Journal title
ACCREDITATION AND QUALITY ASSURANCE
ISSN journal
09491775 → ACNP
Volume
4
Issue
9-10
Year of publication
1999
Pages
434 - 435
Database
ISI
SICI code
0949-1775(199908/09)4:9-10<434:TVCLAF>2.0.ZU;2-6
Abstract
In 1996, the Virtual Central Laboratory (VCL) concept was presented at the 2nd Conference on Quality [R]evolution in Clinical Laboratories: participat ing laboratories measure calibrators. The outcome of these measurements is used to calculate conversion factors. The obtained factors are subsequently applied to standardize the results of a number of routine chemistry parame ters. This conversion method is now part of a quality system to collect cli nical laboratory data in accordance with the Good Clinical Practice guideli nes on patients participating in clinical trials organized by the pharmaceu tical industry. This approach eliminates the need for centralized laborator y services. Presently over 300 laboratories participate in a number of pan- European clinical trials where the VCL is applied. In this paper our experi ences over the last 2 years will be discussed.