Standardization of procedural implementation in clinical data management with reference to the trials: DTwP-HepB-HIB vaccine (Myfive^TM)vs. Pneumococcal vaccine (NUCOVAC®)

Drug or vaccine safety is the prime concern in clinical trials along with theoverall efficacy. Consequently, it is worthwhile to identify and establish the key processes which ensure consistent outcome in data quality and satisfy applicable safetystandards. This article describes standardization and harmonization of procedures and steps adopted for clinical data management in vaccine studies of Panacea Biotec Ltd. It is expected that the methodological approachmay be adopted as standard operating procedure in compliance with the expectations of Indian Good Clinical Practices.