The organization and conduction of the Rischio&Prevenzione trial, the first large-scale clinical trial in general practice since the Italian ministerial decree of 10 May 2001, offers an opportunity to reconsider the monitoring of large non-hospital trials. The interpretation we have given to the current rules implies a flexible approach, to guarantee patients' rights and the scientific quality of the trial results. We propose a new approach to monitoring in the general practice setting, based on GCP rules and involving a network of NHS local health unit pharmacists, already trained for this purpose. This group will coordinate periodic investigators' meetings, assisted by the trial Scientific and Organizing Committee, following a «collective» monitoring scheme according to which the latest study findings will be presented, problems encountered by the group will be discussed, CRF will be checked, and data sources verified.
|Translated title of the contribution||Monitoring clinical trials in general practice: The experience of Rischio&Prevenzione study and the role of territorial pharmacists|
|Number of pages||6|
|Journal||Giornale Italiano di Farmacia Clinica|
|Publication status||Published - Apr 2005|
ASJC Scopus subject areas
- Pharmacology (medical)