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The sponsor-investigator is responsible for:
- Selecting qualified investigators and monitors.
- Ensuring that the investigational device is shipped only to participating investigators.
- Obtaining investigator agreements.
- Obtaining statements from participating investigators attesting to their commitment to the proper conduct of the investigation.
- Obtaining accurate financial disclosure statements from participating investigators.
- Providing participating investigators with the investigational plan.
- Informing co-investigators of new observations with regard to the investigational device and progress of the study.
- Reviewing on-going investigations, including assuring compliance of all investigators with the protocol, reviewing and evaluating safety and efficacy data of the investigational device, and discontinuing studies that are deemed to pose an unreasonable and significant risk to subjects.