South Carolina Code 44-53-1820. FDA approved clinical trials to treat patients who have certain forms of epilepsy with cannabidiol; principal investigators; subinvestigators
(B) Any physician who is board certified and practicing in an academic medical center in this State and treating patients with severe forms of epilepsy may serve as the principal investigator for such clinical trials if such physician:
Terms Used In South Carolina Code 44-53-1820
- Academic medical center: means a research hospital that operates a medical residency program for physicians and conducts research that involves human subjects, and other hospital research programs conducting research as a subrecipient with the academic medical center as the prime awardee. See South Carolina Code 44-53-1810
- Cannabidiol: means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0. See South Carolina Code 44-53-1810
- Physician: means a doctor of medicine or doctor of osteopathic medicine licensed by the South Carolina Board of Medical Examiners. See South Carolina Code 44-53-1810
(1) applies to and is approved by the United States Food and Drug Administration as the principal investigator in a statewide investigational new drug application; and
(2) receives a license from the United States Drug Enforcement Administration.
(C) Such physician, acting as principal investigator, may include subinvestigators who are also board certified and who practice in an academic medical center in this State and treat patients with severe forms of epilepsy. Such subinvestigators shall comply with subsection (B)(2) of this section.
(D) The principal investigator and all subinvestigators shall adhere to the rules and regulations established by the relevant institutional review board for each participating academic medical center and by the United States Food and Drug Administration, the United States Drug Enforcement Administration, and the National Institute on Drug Abuse.
(E) Nothing in this article prohibits a physician licensed in South Carolina from applying for Investigational New Drug authorization from the United States Food and Drug Administration.