Abstrakt

Comprehensive and effective system of standard operating procedures for investigator-initiated trials

Heike Moenkemann, Rita Pilger, Sylvia Reinecker, Peggy Houben & Ursula Paulu

According to GCP, sponsors and organizations that take over sponsor responsibilities, are responsible for implementing a quality management system with written standard operating procedures (SOPs). Changes in the German Drug Law and Medical Device Act made these principles mandatory also for investigator-initiated trials, in which SOPs had been rarely used until 2000. This changed with the introduction of the (Coordinating) Centers for Clinical Trials as central service units for clinical trials at university hospitals all over Germany since 1999. They constituted a quality management working group which developed concerted SOPs for clinical trials with medicinal products and medical devices as well as SOP templates for trial sites considering the characteristics of academic structures. The SOPs described in this publication have become major instruments to enhance the quality of investigator-initiated trials and to ease the cooperation of (Coordinating) Centers for Clinical Trials.