Same study replicated with or without subcontractors
A systematic investigation that is conducted according to a single Clinical Investigation Plan and takes place at two or more investigation sites in one or more human subjects, undertaken to assess the safety or performance of a medical device.
A report of the investigation outcome showing relevant data of the medical device studied. The data can be used for assessment of the safety and/or performance of the device and as clinical data required for CE-marking of the device.
Essential documentation required according to the SS-EN ISO 14155:2011, Annex E.