PROPOSAL OF GUIDELINES FOR THE SAFE SET-U P OF PHARMACOEPIDEMIOLOGIC STUDIES

In the light of recent experiences and anticipating an increase in sim ilar requests in the future, it seemed very interesting to a drug safe ty executives' group from the pharmaceutical industry to propose guide lines for the set-up and followup of pharmacoepidemiological studies r equested by Health Authorities for the assessment of drug risk. The sc ope of these guidelines is to establish the responsibility of the team s and structures involved in the study, to define the necessary stages set-up, and to determine the rules in order to ensure its smooth runn ing from the drafting of the protocole to the final use of the data.