Auditoría de ensayos clínicos en Argentina. Evaluación de procedimientos operacionales normatizados en 12 centros
[Audit of clinical trials in Argentina. Assessment of standardized operational procedures in 12 centers]
Medicina (B.Aires); 51 (6), 1991
The purpose of these audits was to ensure the quality, integrity and validity of investigational data. Audits were performed by control of compliance to standard operational procedures (SOPs) for Good Clinical Practice (GCP). Guidelines were proposed and established by the Food and Drug Administration (F...