Abstract

SAFETY DATA GENERATION IN GUIDANCE OF GOOD CLINICAL PRACTICE BY INTERNATIONAL COUNCIL FOR HARMONISATION (ICH) GUIDELINES

Komal Singh*, Sunil Kumar and Umesh Kumar Sharma

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Abstract

There has been an increased prominence on the proactive and extensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the prime disease, it is important to plan for an extensive safety evaluation at the start of any development program. Statisticians should be informally involved in this process and contribute their prowess to study design, safety data collection, analysis, reporting (including data visualization), and elucidation.

Keywords: Adverse events, clinical trials, safety monitoring, GLP, life intimidating etc.