Coagulation Assays to Assess Rivaroxaban Pharmacodynamics
Coagulation Assays to Assess Rivaroxaban Pharmacodynamics Sample Clauses
Related to Coagulation Assays to Assess Rivaroxaban Pharmacodynamics
Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.
Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.
Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.
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).
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.
RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.
Health Screening The Contractor shall conduct a Health Needs Screen (HNS) for new members that enroll in the Contractor’s plan. The HNS will be used to identify the member’s physical and/or behavioral health care needs, special health care needs, as well as the need for disease management, care management and/or case management services set forth in Section 3.8. The HNS may be conducted in person, by phone, online or by mail. The Contractor shall use the standard health screening tool developed by OMPP, i.e., the Health Needs Screening Tool, but is permitted to supplement the OMPP Health Needs Screening Tool with additional questions developed by the Contractor. Any additions to the OMPP Health Needs Screening Tool shall be approved by OMPP. The HNS shall be conducted within ninety (90) calendar days of the Contractor’s receipt of a new member’s fully eligible file from the State. The Contractor is encouraged to conduct the HNS at the same time it assists the member in making a PMP selection. The Contractor shall also be required to conduct a subsequent health screening or comprehensive health assessment if a member’s health care status is determined to have changed since the original screening, such as evidence of overutilization of health care services as identified through such methods as claims review. Non-clinical staff may conduct the HNS. The results of the HNS shall be transferred to OMPP in the form and manner set forth by OMPP. As part of this contract, the Contractor shall not be required to conduct HNS for members enrolled in the Contractor’s plan prior to January 1, 2017 unless a change in the member’s health care status indicates the need to conduct a health screening. For purposes of the HNS requirement, new members are defined as members that have not been enrolled in the Contractor’s plan in the previous twelve (12) months. Data from the HNS or NOP form, current medications and self-reported medical conditions will be used to develop stratification levels for members in Hoosier Healthwise. The Contractor may use its own proprietary stratification methodology to determine which members should be referred to specific care coordination services ranging from disease management to complex case management. OMPP shall apply its own stratification methodology which may, in future years, be used to link stratification level to the per member per month capitation rate. The initial HNS shall be followed by a detailed Comprehensive Health Assessment Tool (CHAT) by a health care professional when a member is identified through the HNS as having a special health care need, as set forth in Section 4.2.4, or when there is a need to follow up on problem areas found in the initial HNS. The detailed CHAT may include, but is not limited to, discussion with the member, a review of the member’s claims history and/or contact with the member’s family or health care providers. These interactions shall be documented and shall be available for review by OMPP. The Contractor shall keep up-to-date records of all members found to have special health care needs based on the initial screening, including documentation of the follow-up detailed CHAT and contacts with the member, their family or health care providers.
Diagnostic procedures to aid the Provider in determining required dental treatment.
Tuberculosis Examination The examination shall consist of an approved intradermal tuberculosis test, which, if positive, shall be followed by an X-ray of the lungs. Nothing in Sections 5163 to 5163.2, inclusive, shall prevent the governing body of any city or county, upon recommendation of the local health officer, from establishing a rule requiring a more extensive or more frequent examination than required by Section 5163 and this section. § 5163.2. Technician taking X-ray film; Interpretation of X-ray The X-ray film may be taken by a competent and qualified X-ray technician if the X-ray film is subsequently interpreted by a licensed physician and surgeon.
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.
