RESULTS OF STUDY-MONITORING OF A CONTROLLED CLINICAL DOUBLE-BLIND-STUDY

Planning, realisation and evaluation of controlled clinical studies require a steady follow-up of methodological and statistical rules, especially, a continuous study-monitoring. Study-monitoring is necessary to examine side effects and to achieve a complete data-aquisition, -documentation and -handling. Results of study-monitoring of a bicenter, randomized double-blind study have shown, that average 1,3-1,5% of total dates of a study-protocol were to correct, the incidence of lost dates by main parameters was under 11% and the rate of false dates in the computer-aided data-bases was 1,6%.