Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.
Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.
Radionuclide means a radioactive element or a radioactive isotope.
Carcinogen means a chemical that causes an increased incidence of benign or malignant neoplasms, or a substantial decrease in the latency period between exposure and onset of neoplasms through oral or dermal exposure, or through inhalation exposure when the cancer occurs at nonrespiratory sites in at least one (1) mammalian species or man through epidemiological studies or clinical studies, or both.
Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.
Microorganisms (1 2) means bacteria, viruses, mycoplasms, rickettsiae, chlamydiae or fungi, whether natural, enhanced or modified, either in the form of "isolated live cultures" or as material including living material which has been deliberately inoculated or contaminated with such cultures.
HIV means human immunodeficiency virus.
Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
Iatrogenic infertility means an impairment of fertility by surgery, radiation, chemotherapy, or other medical treatment affecting reproductive organs or processes.
Tissue means a portion of the human body other than an organ or an eye. The term does not include blood unless the blood is donated for the purpose of research or education.
Nicotine product means a product that contains nicotine and is not any of the following:
Invasive species means an alien species whose introduction does or is likely to cause economic or environmental harm or harm to human health.
Animal means any nonhuman animate being endowed with the power of voluntary action.
Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.
Aquatic invasive species means any invasive, prohibited,
Compounds means a small molecule HMT inhibitor.
Pathogen means an organism that is capable of producing an infection or disease in a susceptible host.
Halogen means one of the chemical elements chlorine, bromine or iodine.
Cannabinoid extract means a substance obtained by separating cannabinoids from marijuana by:
Explosive material means any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.
Prosthesis means an artificial substitute for a missing body part.
Polystyrene foam adhesive means an aerosol adhesive designed to bond polystyrene foam to substrates.
Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.