Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Organ Transplants This plan covers organ and tissue transplants when ordered by a physician, is medically necessary, and is not an experimental or investigational procedure. Examples of covered transplant services include but are not limited to: heart, heart-lung, lung, liver, small intestine, pancreas, kidney, cornea, small bowel, and bone marrow. Allogenic bone marrow transplant covered healthcare services include medical and surgical services for the matching participant donor and the recipient. However, Human Leukocyte Antigen testing is covered as indicated in the Summary of Medical Benefits. For details see Human Leukocyte Antigen Testing section. This plan covers high dose chemotherapy and radiation services related to autologous bone marrow transplantation to the extent required under R.I. Law § 27-20-60. See Experimental or Investigational Services in Section 3 for additional information. To speak to a representative in our Case Management Department please call 1-401- 000-0000 or 1-888-727-2300 ext. 2273. The national transplant network program is called the Blue Distinction Centers for Transplants. SM For more information about the Blue Distinction Centers for TransplantsSM call our Customer Service Department or visit our website. When the recipient is a covered member under this plan, the following services are also covered: • obtaining donated organs (including removal from a cadaver); • donor medical and surgical expenses related to obtaining the organ that are integral to the harvesting or directly related to the donation and limited to treatment occurring during the same stay as the harvesting and treatment received during standard post- operative care; and • transportation of the organ from donor to the recipient. The amount you pay for transplant services, for the recipient and eligible donor, is based on the type of service.
Trials The Ship shall run the following test and trials:
Biological Samples If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.
Diagnostic procedures to aid the Provider in determining required dental treatment.
Diagnosis For a condition to be considered a covered illness or disorder, copies of laboratory tests results, X-rays, or any other report or result of clinical examinations on which the diagnosis was based, are required as part of the positive diagnosis by a physician.
Patients The Dentist shall accept Covered Persons as patients as reasonably permitted by the Dentist's patient load and appointment calendar. The Dentist will provide Covered Dental Services to Covered Persons on the same basis as to the Dentist's other patients (for example: scheduling, quality of service, and fee charges). The Dentist will be solely responsible to Covered Persons for dental advice and treatment; SDC will have no control over Dentist's practice or the dentist-patient relationship.
Placement of DNS probes Probes for measuring DNS parameters shall be placed as near as possible to the DNS resolvers on the networks with the most users across the different geographic regions; care shall be taken not to deploy probes behind high propagation-‐delay links, such as satellite links.
Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
