This standard operating procedure (SOP) describes the coding procedures to be followed when using the Medical Dictionary for Regulatory Activities (MedDRA) for coding medical text in any clinical database management system (CDMS) used by the DM group.When data are managed by the VIETSTAR BIOMEDICAL RESEARCH DM group, VIETSTAR BIOMEDICAL RESEARCH uses a standardized collaborative procedure involving data management, clinical, and statistical staff to ensure the addition of appropriate medical codes to study text data
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