Good Clinical Practice and study monitoring: results of an Italian survey of the clinical monitor

Abstract

1. A questionnaire, prepared to define the profile of the clinical monitor, was sent to pharmaceutical companies and contract research organisations (CROs) in Italy. Out of 70 organisations contacted, 51 questionnaires (71%) were returned by the end of 1997. 2. The sample size was 434 clinical monitors, of which most (94.7%) were graduates in biology, pharmacy or medicine. The profile, as defined in the ICH-4, was met in 60%. 3. All received basic training on Good Clinical Practice (GCP), half through in-house courses. Only 5% of the pharmaceutical companies provided additional training on specific scientific aspects of the clinical protocols. 4. Overall 44% were based in the field but this percentage was 77.8% when only the CROs were considered. For the pharmaceutical companies, the workload was calculated according to the number of investigational sites to be monitored (mean, 10 sites), while the number of visits per month was preferred by the CROs. 5. The monitoring activity was always performed in accordance with proper standard operating procedures. 6. The profile of the clinical monitor in Italy fits the international requirements, despite some differences between pharmaceutical companies and CROs.