[Good practices in clinical trials. Quality control of biological trials in hospital laboratory].
All along clinical studies of a new drug, during the second, third, or fourth phase, the hospital laboratory occurs in the biological tolerance supervision. Therefore, it calls on a number of quality controls, either voluntary or obligatory: patient identity control, analytical quality controls: between and within laboratory, regional and national controls, biological quality control. Beside these quality controls, that are necessary at the same time for clinical studies and for routine analysis, biological laboratories are submitted on norms of material, area, and employees qualification (Law of July 11th 1975).
Garnier
J P
JP
Laboratoire de Biochimie, Hôpital Saint-Louis, Paris.
Dreux
C
C
D001681:Biological Assay; D002986:Clinical Trials as Topic / Q000379:methods*; D004341:Drug Evaluation / Q000379:methods*; D006801:Humans; D007755:Laboratories, Hospital / Q000458:organization & administration; D011786:Quality Control