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Glossary

CIOMS I Form

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A form used to notify the relevant authorities of the Individual Case Safety Report (ICSR) in most countries. The form has to be completed by the investigator and, after verification, provided by the sponsor to the competent authorities or to the partner company (subcontractor) in charge of the reporting.

Other glossary definitions

H

Health Technology Assessment

HTA is a multidisciplinary process that summarises information about the medical, social, economic, and ethical…

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D

Development safety update report (DSUR)

Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of…

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