Description

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.

Resources

Name	Format	Description	Link
Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/structure-content-clinical-study-reports-topic-health-canada-1996.html
Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/structure-content-clinical-study-reports-topic-health-canada-1996.html

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