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

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. 2023-12-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetystructure and contentclinical study reportsICH Topic E3guidance for industrysingle-core clinical-study reportregulatory authoritiesICH regions Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industryHTML 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 industryHTML 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

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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