Pennsylvania Code & Bulletin
COMMONWEALTH OF PENNSYLVANIA

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28 Pa. Code § 1211.21. Definitions.

§ 1211.21. Definitions.

 The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   ACRC—An accredited medical school in this Commonwealth that operates or partners with an acute care hospital licensed and operating in this Commonwealth.

   Accredited medical school—An institution that is:

     (i)   Located in this Commonwealth.

     (ii)   Accredited by the Liaison Committee of Medical Education or the Commission on Osteopathic College Accreditation.

   Acute care hospital—A facility having an organized medical staff that provides equipment and services primarily for inpatient medical care and other related services to persons who require definitive diagnosis or treatment, or both, for injury, illness, pregnancy or other disability and is licensed by the Department to operate as a hospital in this Commonwealth under the Health Care Facilities Act (35 P.S. § §  448.101—448.904b) and the regulations promulgated thereunder.

   Applicant—A person who submits an application to the Department to become an approved clinical registrant.

   Approved clinical registrant—An entity that applied for and received the approval of the Department to do all of the following:

     (i)   Hold a permit as both a grower/processor and a dispensary.

     (ii)   Enter into a research contract with a certified ACRC.

   Certified ACRC—An ACRC that has applied for and has been certified by the Department to enter into a research contract with an approved clinical registrant.

   IRB—Institutional review board—A board, committee, RAC or group designated by a certified ACRC that reviews and approves the anticipated scope of an approved clinical registrant’s research study involving human subjects under the criteria in 45 CFR 46.111 (relating to criteria for IRB approval of research) and 21 CFR 56.111 (relating to criteria for IRB approval of research).

   Institution of higher education—A community college, State-owned institution, State-related institution, or private college or university approved by the Department of Education.

   RAC—Research approval committee—A board, committee or group created or designated by a certified ACRC to review and approve the scope and research protocols of a research program proposed by an approved clinical registrant.

   Research—Any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

   Research contract—A written agreement between an approved clinical registrant and a certified ACRC that contains the responsibilities and duties of each party with respect to the research program or research study that the approved clinical registrant and the certified ACRC intend to conduct under this chapter and under which the certified ACRC will provide medical advice to the approved clinical registrant regarding, among other areas, patient health and safety, medical applications, and dispensing and management of controlled substances. This term shall include a letter of intent to enter into an agreement for purposes of a clinical registrant application.

   Research program—Research on the therapeutic or palliative efficacy of medical marijuana limited to the serious medical conditions defined by the act and this part.

   Research project or study—Any other research on medical marijuana or its effectiveness in treating a medical or psychological condition.

   Research protocol—A written procedure for conducting a research program or research study that includes all of the following information:

     (i)   With respect to the investigator:

       (A)   Name and address.

       (B)   Institutional affiliation.

       (C)   Qualifications, including a curriculum vitae and list of publications, if any.

     (ii)   With respect to the research program or research study:

       (A)   Title of the research program or research study.

       (B)   Statement of the purpose.

       (C)   Type of medical marijuana product involved and the amount needed.

       (D)   Description of the research to be conducted, including the number and type of medical marijuana product, the dosage, the route and method of administration, and the duration of the research program or research study.

       (E)   The locations of the dispensaries that will be participating in the research program or research study.

Authority

   The temporary provisions of this §  1211.21 amended under the Medical Marijuana Act (35 P.S. § §  10231.101—10231.2110).

Source

   The temporary provisions of this §  1211.21 amended December 21, 2018, effective December 22, 2018, 48 Pa.B. 7778. Immediately preceding text appears at serial pages (393535) to (393537).



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