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- Title
Regulatory Writing.
- Authors
Morley, Greg
- Abstract
The article discusses the clinical study report (CSR) discussion session which is frequent source of doubt to medical writers. The shorter is better approach is widely applicable especially to CSR's that will usually be read as component of a submission. The International Conference on Harmonisation (ICH) issued set of questions and answers regarding the ICH E3 guideline on the content and structure of CSR's which refers to safety and efficacy studies.
- Subjects
EDUCATIONAL reports; REPORT writing; AUTHORSHIP; CLINICAL medical education; COMPOSITION (Language arts); INTERNATIONAL Conference on Harmonisation
- Publication
Medical Writing, 2012, Vol 21, Issue 4, p317
- ISSN
2047-4806
- Publication type
Article
- DOI
10.1179/2047480612Z.00000000077