[Differences and similarities of industrial and institutional promotions].
The Délégation à la Recherche Clinique d'Ile-de-France et de l'Assistance Publique/Hôpitaux de Paris (AP-HP) has elaborated a pragmatic approach for the monitoring of institutionally sponsored clinical studies. The mandatory practices aiming at preventing enrolled volunteers from risks and results from fraud and poor quality have been reviewed and a four-stage graduate monitoring has been defined, which is applied since 2002. This system needs to be scientifically assessed and adapted to the permanent evolution of national and international regulations. double dagger.
Ménard
Joël
J
Faculté de Médecine René Descartes, SPIM, 15, rue de l'Ecole de Médecine, 75270 Paris Cedex 06, France. Joel.menard@spim.jussieu.fr
Daurat
Véronique
V
D035843:Biomedical Research / Q000941:ethics* / Q000592:standards*; D004991:Ethics, Institutional; D005602:France; D007221:Industry / Q000941:ethics*