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.
Quality by Design,
Quality Management System, Quality assurance, Good clinical Practice.
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doing what you always did http://www.chiltern.com/pdf/customers/Chiltern%20v2-%20QRM.pdf.
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Research: New Recommendations and Tool for Research. https://www.ctti-clinicalResearch.org/.
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quality of conduct of clinical Research: A survey of current practices.
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Data-Driven Quality Management System Can Manage Compliance Risk in Clinical
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