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
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.