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Glossary

Comparative Effectiveness Research (CER)

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The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat, and monitor health conditions in routine clinical practice (i.e. the real-world setting).

Comparative effectiveness research includes both primary data collection and secondary analyses (such as systematic literature reviews, meta-analyses and economic evaluations).

Other glossary definitions

P

Pre-Market Notification (510(k))

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical…

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S

Significant risk device

An investigational device that:  Is intended as an implant and presents a potential for serious…

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