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Project Management Plan

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The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

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International Committee for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is…

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Lay Person Summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of…

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