Who is responsible for what?
During the phase I trials, from the juridical point of view, the responsibilities are shared between the pharmaceutical company and the physician who manages the trial. The pharmaceutical company is responsible for the product, the choice of methodology and respect for the regulations. On the financial side, the company is liable for paying any damages. While the trial is being conducted, the physician is responsible both for the choice of the healthy volunteers and for their care.
Rouzioux
J M
JM
Institut Mérieux, Marcy-l'Etoile, France.
D004341:Drug Evaluation / Q000639:trends*; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D005602:France; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D012107:Research Design