Quality assurance in clinical trials.
From the literature that was initially searched by electronic databases using the keywords quality, quality control and quality assurance in combination with clinical trials, surgery, pathology, radiotherapy, chemotherapy and data management, a comprehensive review is given on what quality assurance means, the various methods used for quality assurance in different aspects of clinical trials and the impact of this quality assurance on outcome and every day practice.
Ottevanger
P B
PB
Department of Internal Medicine, Division of Medical Oncology, 550, University Hospital Nijmegen, Geert Grooteplein 8, PO 9101, 6500HB Nijmegen, The Netherlands. p.ottevanger@onco.umcn.nl
Therasse
P
P
van de Velde
C
C
Bernier
J
J
van Krieken
H
H
Grol
R
R
De Mulder
P
P
D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D008495:Medical Oncology / Q000379:methods / Q000592:standards; D009369:Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D011785:Quality Assurance, Health Care; D011786:Quality Control; D016896:Treatment Outcome