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.
Infusion Therapy the administration of antibiotic, nutrients, or other therapeutic agents by direct infusion. Note: The limitations on Therapy Services contained in this Therapy Services provision do not apply to any Therapy Services that are received under the Home Health Care provision or to therapy services received under the Diagnosis and Treatment of Autism or Other Developmental Disabilities provision. .
Musculoskeletal Injury Prevention and Control (a) The Hospital in consultation with the Joint Health and Safety Committee (JHSC) shall develop, establish and put into effect, musculoskeletal prevention and control measures, procedures, practices and training for the health and safety of employees.
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.
Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.
Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).
Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.
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.
Diagnostic procedures to aid the Provider in determining required dental treatment.
Treatment Program Testing The Employer may request or require an employee to undergo drug and alcohol testing if the employee has been referred by the employer for chemical dependency treatment or evaluation or is participating in a chemical dependency treatment program under an employee benefit plan, in which case the employee may be requested or required to undergo drug or alcohol testing without prior notice during the evaluation or treatment period and for a period of up to two years following completion of any prescribed chemical dependency treatment program.
