Clinical R&D

1. Corporate practice of medicine requirements in California.

2. What services can companies employees perform (independently or under the supervision of licensed staff from a professional corporation)?

3. What services must be performed by licensed staff from a professional corporation contracted by company?

4. Facility licensure requirements

5. Applicability of HIPAA and California privacy laws to research that will be conducted at the facility

6. Company employee participation in research at the facility

7. Informed consent and recruitment

8. Separation between sponsor and study site roles