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Glossary

Anonymization Report (AR)

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Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical reports, and how the risk of re-identification has been addressed.

Other glossary definitions

M

Misuse of a medicinal product for illegal purposes

Misuse for illegal purposes is misuse with the additional connotation of an intention of misusing…

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I

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical…

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