Abstract:

Clinical Research is an investigation in humans anticipated to decide or confirm the effects of a drug or to identify any adverse reactions with an intention of ascertaining its safety and efficacy. Quality of clinical Research relies on data consistency and subject safety. Quality control and quality assurance are part of quality management systems. There is an increasing focus on having quality systems in place throughout the planning stages of clinical Research. The regulatory outline for clinical Research has altered in recent years with the addition of thorough controls to guarantee patient protection and data dependability. There is a clear requisite to execute the principles of planned quality management in health research to avoid failure, take full advantage of the utilization of offered resources and guarantee reliability and integrity of results. Ideally, all clinical Research ought to have a Clinical Research Quality Management Plan (CRQMP) describing the tools that will be used to guarantee study quality. Adoption of quality-by-design (QbD) and quality risk management methods for clinical Research management is the current mantra at FDA.

KEYWORDS

Quality by Design, Quality Management System, Quality assurance, Good clinical Practice.

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