title: Quality assurance in EORTC clinical trials. European Organisation for Research and Treatment of Cancer.
abstract: Quality assurance (QA) has become a major factor over recent years in the management and analysis of clinical trials. The EORTC recognised very early the importance of QA in clinical data handling and started in 1992 with the development of the first SOP in the format of a 'Procedures manual' which, from the beginning, had incorporated the EU GCP guidelines. In 1995, a Quality Assurance Unit (QAU) was created to coordinate the various QA activities and to guarantee that all clinical trials do comply at all levels with a minimum of QA requirements. The QAU coordinates internal and external audits and is a mandatory partner in the audits performed by national/international authorities and pharmaceutical industries. This process has been prolonged at the Data Center with the development of a full set of standard operating procedures (SOPs), the implementation of training programmes for each category of staff and an ongoing interval monitoring process.
authors.affiliation: EORTC Data Center, Avenue E. Mounier 83, bte 11, B-1200, Brussels, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Marinus
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D005060:Europe; D006801:Humans; D007390:International Agencies / Q000592:standards*; D008495:Medical Oncology / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration*