Good Clinical Practice and study monitoring: results of an Italian survey of the clinical monitor
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INTERNATIONAL JOURNAL OF PHARMACEUTICAL MEDICINE 2000, 14:23±25
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ORIGINAL ARTICLE ......................................................................................................................................................................
Good Clinical Practice and study monitoring: results of an Italian survey of the clinical monitor F. DeTomasi* and C. Zannay *Associate Regional Director CR&D,Wyeth-Lederle SpA., Aprilia (LT), Italy. yHead Clinical Research II, Sigma-Tau SpA., Pomezia (RM), Italy. Correspondence to Dr Francesco De Tomasi, Wyeth-Lederle SpA., via Nettunense 90, I-04011 Aprilia (LT), Italy. Received 6 September 1999; accepted 14 January 2000
Summary
1. A questionnaire, prepared to de®ne the pro®le 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 pro®le, as de®ned 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 speci®c scienti®c aspects of the clinical protocols. 4. Overall 44% were based in the ®eld 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 pro®le of the clinical monitor in Italy ®ts the international requirements, despite some differences between pharmaceutical companies and CROs. Keywords: questionnaire survey, Italian clinical monitors, pharmaceutical companies, contract research organisations, profile of training and workload.
Introduction During the last decade, many new regulations and guidelines for conducting clinical trials have been produced. In particular, Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) have improved the standards [1±3]. The clinical monitor has been identi®ed as the key person to ensure full compliance with these requirements. A clinical monitor, in accordance with the ICH-4 criteria, should be a
On behalf of a Working Group of the Society for Applied Pharmaceutical Sciences (SSFA).
quali®ed person appointed by a sponsor and having a documented scienti®c and/or clinical knowledge. Furthermore, the clinical monitor should be adequately trained in order to be familiar with the study that he or she will monitored, with the standard operating procedures (SOPs), with GCP and with the applicable regulatory requirements. In practice, however, there are many differences in the pro®le of the clinical monitor from company to company and from country to country. Ther
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