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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

Marketing Authorization Application (MAA)

The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that…

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I

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent…

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