Quality assurance in EORTC clinical trials

Quality assurance (QA) has become a major factor over recent bears in the management and analysis of clinical trials. The EORTC recognised very earls 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) vas 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. (C) 2002 Elsevier Science Ltd. All rights reserved.