i. Selection and monitoring of investigators 21 CFR 312.53 – 312.56

The sponsor-investigator is responsible for:

1. Selecting qualified investigators and monitors.
2. Ensuring that the study drug is shipped only to participating investigators.
3. Informing co-investigators of new observations with regard to the investigational drug and progress of the study.
4. Reviewing on-going investigations, including assuring compliance of all investigators with the protocol, reviewing and evaluating safety and efficacy data of the investigational drug, and discontinuing studies that are deemed to pose an unreasonable and significant risk to subjects.