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Glossary

Integrated summary of Safety (ISS)

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Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.

Other glossary definitions

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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C

Case Report Form (CRF)

Data collected in the frame of a clinical trial must be recorded in order to…

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