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Glossary

Development safety update report (DSUR)

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Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

Other glossary definitions

J

Justification Table

In relation to Policy 70, to be completed by the Applicant to justify the proposed…

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N

Non-substantial Amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does…

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