[Hospital pharmacy and clinical trials. Requirement of procedures and protocol of administration and distribution of drug].
Law established a holding and a distribution, by the hospital pharmacist, of the clinical trial drugs. These operations can only be achieved with written procedures. Two sorts of procedures are required: general procedures for the whole of trials and special procedures for each of them. In that setting, a protocol for administration and distribution of drug involved in one study is established. It is intended for the three partners of the trial: sponsor, clinical investigator, and pharmaceutical department itself. It gives to these partners all the relevant informations so as to lead the operations and their chronology. This system has been acting in the hospital for a year. It appeared reliable for the three partners in about thirty trials. So, it can be considered as validated.
Ferry
S
S
Service Pharmaceutique, Hôpital Neuro-Cardiologique, Lyon.
Goubier
C
C
D002986:Clinical Trials as Topic / Q000379:methods*; D005602:France; D006801:Humans; D008510:Medication Systems, Hospital / Q000458:organization & administration*; D010607:Pharmacy Service, Hospital / Q000458:organization & administration*