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Description
EBMT AUDIT PROGRAM I. Background Data transmission from individual centres to EBMT registries has been based on mutual trust right from the start. This continues to be the basis for data transfer. However, verification of data is required today in many instances for scientific publications. Accreditation also depends on some control mechanisms. At the Annual Meeting in Vienna in 1996, the EBMT general assembly approved introducing an audit program, which was successfully initiated in 1997. In 2003 the requirement to check for informed patient consent was added, to ensure compliance with EU directive (95/46/EC) regulating personal data II. Objectives To ascertain the presence of an institutional unique patient number list (UPN list), verify consecutive case reporting and control accuracy of reported data, as compared to institutional medical records. In 2003 the requirement to check for informed consent has been added, to ensure compliance with EU directive (95/46/EC) regulating personal data. III. Audit operationsEBMT members are subject to be audited once every three years. Ten institutions are first selected randomly. For each of these teams, a board or working party member near the institution is identified, and three convenient times are chosen for the audit. Auditors are asked to sign a waiver stating that they have no political, financial, or other conflict of interest with the team to be audited prior to notifying the team ...
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English