[Application of good clinical practices. An example of organization].
The quality of clinical trials is guaranteed by good clinical practices (GCP). An evaluation of data and patient safety is evaluated for each procedure making up GCP. Compliance to GCP is required for clinical trials performed in France to gain international recognition. Several pharmaceutical firms have modified their trial procedures in order to assure application of GCP. Key posts for monitors and clinical research assistants have been created. They play a major role in following up clinical trials and control the application of pre-established standardized procedure. Follow-up documents provide written proof of how GPC were applied and also add credibility to the trial during an audit or inspection. In the hospital setting, clinics, research centres, pharmaceutical units, and dispensaries are also largely implicated in the quality of the trial. Each must have adequate means of applying GCP with the aim of improving the signification of medical observation during therapeutic trials.
Nys
V
V
Hôpitaux de Paris, Nanterre.
Terrier
J L
JL
Certain
B
B
Costantini
D
D
D002986:Clinical Trials as Topic / Q000592:standards*; D004282:Documentation; D010818:Practice Patterns, Physicians' / Q000458:organization & administration* / Q000592:standards