Responsibilities of Sponsors and Investigators

1 SELECTING QUALIFIED INVESTIGATORS 2 PROVIDING THEM WITH THE INFORMATION they need to conduct an investigation properly 3 ENSURING PROPER MONITORING of investigation, 4 ensuring that the investigation is conducted in ACCORDANCE WITH THE GENERAL INVESTIGATIONAL PLAN and protocols contained in the IND 5 ensuring that FDA and all participating INVESTIGATORS are promptly INFORMED OF SIGNIFICANT NEW ADVERSE EFFECTS OR RISKS