b. General responsibilities of sponsors 21 CFR 312.50

The sponsor-investigator is responsible for:

1. Selecting qualified investigators and providing them with the information they need to conduct an investigation properly.
2. Ensuring proper monitoring of the investigation.
3. Ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND.
4. Maintaining an effective IND with respect to the investigations.
5. Complying with FDA regulations with regard to the promotion and charging for investigational new drugs. 
6. Ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug.