The Necessity of an Electronic SOP Retrieval System

OBJECTIVES Standard Operating Procedures (SOP) are part of the quality management system when carrying out clinical trials. It is therefore important for all those envolved to know about them and act accordingly. This survey should help to detect problems concerning the handling of SOP during clinical trials. METHOD Anonymous survey of all employees of the Koordinierungszentren Klinische Studien (KKS) in Germany by means of standardised questionnaires (238 employees in August 2004 according to the KKS homepages). RESULT 58,8% of all evaluation sheets were sent back proving that paper-based as well as electronic SOP systems are not sufficiently integrated into everyday work procedures. CONCLUSION Steps will have to be taken in order to increase the use of SOP. We propose a computer-based retrieval tool (SOP Information Retrieval System).