II monitoraggio degli studi clinici in medicina generale: La proposta di Rischio&Prevenzione e il ruolo dei farmacisti territoriali

Translated title of the contribution: Monitoring clinical trials in general practice: The experience of Rischio&Prevenzione study and the role of territorial pharmacists

Ierta Pangrazzi, Lara Monesi, Irene Marzona, Giusy Silletta, Carla Roncaglioni, Roberta Joppi, Desiree Bastarolo, Alessia Confente, Giuseppe Lombardo

Research output: Contribution to journalArticle

Abstract

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 contributionMonitoring clinical trials in general practice: The experience of Rischio&Prevenzione study and the role of territorial pharmacists
Original languageItalian
Pages (from-to)89-94
Number of pages6
JournalGiornale Italiano di Farmacia Clinica
Volume19
Issue number2
Publication statusPublished - Apr 2005

ASJC Scopus subject areas

  • Pharmacology (medical)

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