Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry (French, HTML)
View metadata and access the original French HTML file: Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry.
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- HTML
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- file-only
- Publisher-reported update
- 2023-12-29
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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- HTML
- File languages
- French
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