Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry

The objective of this guidance document is to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements.

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Title (French) Structure et contenu des rapports d'étude clinique ICH thème E3 : Ligne directrice à l'intention de l'industrie
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Open Canada Date Published 2020-12-09 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["structure et contenu", "rapports d'études cliniques", "ICH Topic E3", "lignes directrices pour l'industrie", "rapport d'étude clinique monocœur", "autorités réglementaires", "régions ICH"], "en": ["structure and content", "clinical study reports", "ICH Topic E3", "guidance for industry", "single-core clinical-study report", "regulatory authorities", "ICH regions"]}
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