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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

P

Patient Information Leaflet (PIL)

Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally…

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M

Medical Device (MDR definition)

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer…

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