Qualitätssicherung in der klinischen Prüfung
Erfahrungen mit einem Systemaudit zur Qualitätssicherung bei den Mitgliedern des Bundesverbandes Medizinischer Auftragsinstitute (BVMA) e.V.
Dr. med. vet. Sylvia Ludwig und der Vorstand des BVMA (Dr. biol. hum. Dagmar Chase, Dr. med. vet. Michael Gierend, Prof. Dr. med Heinz Letzel) für die Mitglieder des BVMA
Quality Assurance in Clinical Trials / Experiences with a System Audit for Assuring Quality with the Member CROs of the Bundesverband Medizinischer Auftragsinstitute (BVMA) e.V
The members of the Bundesverband Medizinischer Auftragsinstitute (BVMA, Federal Association of Contract Research Organisations CROs) are scientific enterprises offering services in clinical drug research. 17 members of the BVMA underwent an independent external system audit according to a uniform standard for the first time in medical contract research in Germany. The audit organisation commissioned planned the system audit in harmonisation with the BVMA and prepared a special audit-SOP. The overall result of the system audit was remarkably positive: No serious findings indicating significant impairments of the quality of offered performances were noted. The remaining findings were classified into 31 majors (significant deviation from GCP and SOPs without impairing quality of performances) and 163 minors (insignificant deviations). The audit findings were described per CRO in a confidential audit report demanding a reaction of the audited member CROs within 28 days. The very high level of quality of the BVMA-members has been documented by this system audit. Further regular reaudits are planned in the future which will be prepared and processed in a newly established BVMA quality assurance working group. Web-site: www.bvma.de
pharmind 2001, Nr. 11, Seite 1128