Okla. Admin. Code § 310:15-3-1

Current through Vol. 42, No. 4, November 1, 2024

Section 310:15-3-1 - Physician application

Any physician, who has been designated a principal investigator of a clinical trial concerning Lennox-Gastaut Syndrome, also known as Severe Myoclonic Epilepsy of Infancy; any other severe form of epilepsy not adequately treated by traditional medical therapies (63 O.S. § 2-101(23) ), or any other form of refractory epilepsy that is not adequately treated by traditional medical therapies, spasticity due to multiple sclerosis or due to paraplegia; intractable nausea and vomiting; or appetite stimulation with chronic wasting diseases (63 O.S. § 2-801(5) ) on individuals, and who requests approval from the Commissioner of Health, or designee shall:

(1) Submit an application on a form provided by the Commissioner of Health, which shall include the name, address and other contact information for the principal investigator;

(2) Submit a statement from either the Oklahoma State Board of Medical Licensure or the Oklahoma State Board of Osteopathic Examiners that the physician is licensed and in good standing with said licensure board;

(3) Submit a copy of the documents from the United States Food and Drug Administration naming the physician as the principal investigator;

(4) Submit a copy of the license obtained by the United States Drug Enforcement Administration;

(5) Submit and maintain a current Oklahoma State Bureau of Narcotics and Dangerous Drugs Control registration;

(6) Demonstrate registration with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control;

(7) Submit the names, addresses and other contact information of any subinvestigators who will be assisting the principal investigator and include with the submission:

(A) A copy of the license obtained by the United States Drug Enforcement Administration; and

(B) Information demonstrating registration of the subinvestigator with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control;

(8) Submit the following information concerning the clinical trial to be performed:

(A) Name, address and contact information of the academic medical center where the clinical trial will occur;

(B) Statement from Institutional Review Board (IRB) of the academic medical center where the clinical trial will occur, concurring with the requirements for said clinical trial;

(C) Statement from the United States Food and Drug Administration allowing cannabidiol to be used as a investigation new drug on qualified patients with severe forms of epilepsy;

(D) Name, address and other contact information of the source of the cannabidiol to be used for the study. The submission of the information of the source of the cannabidiol shall include:

(i) Information that the cannabidiol was manufactured at a facility in the United States or in a foreign country that was approved by the United States Food and Drug Administration; and

(ii) Information that the cannabidiol has been tested on animals to:

(I) demonstrate preliminary effectiveness; and

(II) ensure the cannabidiol is safe to administer to humans;

(E) Submit a statement that the clinical trial will be performed at the highest standards of clinical research; and

(F) Submit a statement that the clinical trial will conclude no later than December 31, 2017;

(9) Submit a statement that the principal investigator and all subinvestigators shall adhere to the rules and regulations established by the relevant Institutional Review Board for the clinical trial; and

(10) Submit an attestation by the principal investigator as to the accuracy and completeness of the information provided in the application.

Okla. Admin. Code § 310:15-3-1

Adopted by Oklahoma Register, Volume 33, Issue 24, September 1, 2016, eff. 9/11/2016

Amended by Oklahoma Register, Volume 34, Issue 24, September 1, 2017, eff. 10/1/2017