The sponsor shall notify the Medical Products Agency on:
- all serious (confirmed or suspected) adverse events
- essential changes of the CIP
- changes concerning clinical investigator(s)
- changes concerning investigation site(s)
- suspension or preterm conclusion of the investigation
restart of suspended investigation
Notification on changes of the CIP and of investigator(s) shall be signed by the sponsor and the investigator(s) concerned, in case of additional investigation site(s) also by the concerned Head of Department.
The sponsor and the investigator shall regularly inform each other in accordance with SS-EN ISO 14155-1 and the latest version of the CIP.