SSInvestigator object

Additional Information

Investigator (pursuant to Section 13 of Act No 268/2014 Coll. on Medical Devices):
'a medical professional with adequate expert and specialised qualification, appointed by the sponsor of the clinical investigation who safeguards the course of the clinical investigation conducted within a single professional workplace'

Principal investigator (where a multicentric clinical investigation is concerned):
'a medical professional with adequate expert and specialised qualification, appointed by the sponsor of the clinical investigation who is responsible for the coordination and course of the multicentric clinical investigation'

Obligations of the investigator/Principal Investigator of a clinical investigation are specified in Section 20 of Act No 268/2014 Coll. on Medical Devices.

Feedback