Clinical safety data management
Subtitle: definitions and standards for expedited reporting
By: [developed by ICH Expert Working Group].
Contributors: Canada. Health Protection Branch.; International Conference on Harmonisation.
Series: Drugs Directorate guidelines; ICH harmonised tripartite guideline
Publisher: Health Protection Branch, Health and Welfare Canada
Published: 1995
Place of publication: Ottawa, Ont
Language: eng
Subjects: Drugs -- Side effects -- Reporting -- Canada.; Drugs -- Safety measures -- Standards.
Notes: Issued also in French under title: Gestion des données cliniques sur l'innocuité des médicaments : définitions et normes relatives à la déclaration rapide.

"International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use."

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