Safety monitoring

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Safety Monitoring

Safety Monitoring (pronunciation: /ˈseɪfti ˈmɒnɪtərɪŋ/) is a critical aspect of clinical trials and healthcare that involves the ongoing surveillance and analysis of the safety profile of pharmaceutical drugs or medical devices.

Etymology

The term 'Safety Monitoring' is derived from the English words 'safety', meaning the condition of being protected from harm or other non-desirable outcomes, and 'monitoring', which refers to the process of observing and checking the progress or quality of something over a period of time.

Definition

Safety Monitoring in the context of healthcare and clinical trials refers to the collection, analysis, and follow-up of data related to the safety and adverse effects of pharmaceutical drugs or medical devices. It is a crucial part of the risk management process in healthcare, aiming to protect patients from potential harm and ensure the efficacy of the treatment.

Related Terms

  • Pharmacovigilance: The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
  • Adverse Event: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
  • Risk Management: The identification, assessment, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.

See Also

External links

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