Quality Assurance in Clinical Trials
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Int J Pharm Med 2005; 19 (5-6): 275-276 1364-9027/05/0005-0275/$34.95/0 © 2005 Adis Data Information BV. All rights reserved.
Quality Assurance in Clinical Trials Results of the Follow-Up Systems Audit of Member Companies in the BVMA Dagmar Chase, Michael Gierend, Stefan Rettig, and Barbara Schnurr on behalf of the Bundesverband Medizinischer Auftragsinstitute (BVMA) In 1991 the Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA) was founded and, thus, the first German joint representative association of contract research organisations (CROs) was established. Membership of this federal organisation is voluntary. The statutes of the BVMA decree that regular independent quality assurance audits are a requirement of continued membership. Twenty-one companies, operating locally and globally, are currently members of the BVMA; six of whom joined after 2003, following a successful first audit. Only those CROs that have no audit findings can remain within the association or become members of it. This guarantees that members maintain a high standard. ADAMAS Consulting (UK) was selected to perform the external audits, which involved checking that systems, work procedures, and documentation of and adherence to International Conference on Harmonisation Good Clinical Practice (ICH-GCP, CPMP/ICH/135/95[1]) standards were being followed. In 2000 all member companies underwent this audit. To standardise the evaluation of results, ADAMAS classified the individual findings as ‘serious’, ‘major’ or ‘minor’. These were defined as: • Serious audit findings: consistent deviation from or noncompliance with standards, possibly resulting in impaired quality of a service. • Major audit findings: significant deviation from the standards, not resulting in impaired quality. • Minor audit findings: occasional and insignificant deviation from the standards, not resulting in impaired quality. Serious audit findings were regarded as incompatible with membership of the BVMA. None of the companies audited in 2000 were found to have a serious audit finding.[2] Each audited company received an audit certificate, and a further audit was planned for 2003. Since the initial audit showed some weaknesses, particularly in standard operating procedures
(SOPs), these were identified as the main focus for the first follow-up audit. The initial audit lead to a Quality Assurance working group being set up by the BVMA to review the audit results, this group drew up a list of essential SOPs which was endorsed by the BVMA members to represent the compulsory standard for member companies. The list of essential operating procedures (SOPs) was made available to all member companies when they prepared for the re-audit. The SOPs covered the following areas: • general SOPs (including job descriptions and training) • clinical operations • project management • safety • data management • biostatistics • medical writing • contract quality assurance • information technology (IT), including references to part 11 of Code of Federal Regulations • investigational medicin
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