Theorem Clinical Research Offers Reference Booklet for European Medical Device Investigations - Applied Clinical Trials

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Theorem Clinical Research Offers Reference Booklet for European Medical Device Investigations

Source: Applied Clinical Trials

Theorem Clinical Research has released a site-level reference booklet that concentrates on European (EN) International Organization for Standardization (ISO) 14155:2011. The booklet addresses the scope of EN ISO 14155:2011, which is the equivalent of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) for investigational medicinal products and is commonly called the modern GCP for investigational medical devices for human subjects.The booklet also covers common terms and abbreviations, tips for categorizing adverse events, ethical considerations, responsibilities of the sponsor and advice on clinical investigation planning, conduct, suspension, termination and closeout. This booklet is available for purchase online.

Read the full release here.

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