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

Name: Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-12-29

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry (English, HTML) HTML
Structure and Content of Clinical Study Reports ICH Topic E3: Guidance for industry (French, HTML) HTML

Related open data

Health Canada