Blinding of Investigational Medicinal Product Sample Clauses

Blinding of Investigational Medicinal Product. All IMP administrations, including retreatments, will be double blind, although only the first treatment is placebo controlled. Subjects, investigators and all study staff will remain blinded to treatment assignment throughout the study. CCI
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Related to Blinding of Investigational Medicinal Product

  • 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.

  • 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.

  • 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.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • 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.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • 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.

  • Traditional Medicine Cooperation 1. The aims of Traditional Medicine cooperation will be: (a) to build on existing agreements or arrangements already in place for Traditional Medicine cooperation; and (b) to promote information exchanges on Traditional Medicine between the Parties. 2. In pursuit of the objectives in Article 149 (Objectives), the Parties will encourage and facilitate, as appropriate, the following activities, including, but not limited to: (a) encouraging dialogue on Traditional Medicine policies and promotion of respective Traditional Medicine; (b) raising awareness of active effects of Traditional Medicine; (c) encouraging exchange of experience in conservation and restoration of Traditional Medicine; (d) encouraging exchange of experience on management, research and development for Traditional Medicine; (e) encouraging cooperation in the Traditional Medicine education field, mainly through training programs and means of communication; (f) having a consultation mechanism between the Parties' Traditional Medicine authorities; (g) encouraging cooperation in Traditional Medicine therapeutic services and products manufacturing; and (h) encouraging cooperation in research in the fields of Traditional Medicine in order to contribute in efficacy and safety assessments of natural resources and products used in health care.

  • Formal Investigation Once the matter has been brought to the attention of the Store executive, an internal investigation of the complaint will be conducted at which time the complainant will be requested to present, in writing, the particulars of the harassment. Such internal investigation will be initiated no later than ten (10) business days of the matter being brought to the attention of the Store executive, and shall be concluded no later than thirty (30) business days of the initiation of the investigation. Any extension of the aforementioned time frames must have the agreement of the complainant and the union if the complainant has chosen to involve it. Based on the outcome of the investigation, which will be provided in writing upon the completion of the investigation, to both the complainant and the union, should the complainant consent to this disclosure, it will be determined if there has been a breach of Company policy on harassment, and the appropriate action will be taken in the event that harassment is determined to have occurred. STEP THREE - SUBSEQUENT INCIDENTS Subsequent incidents should immediately be reported and followed by a written description to the most senior store executive involved in Step Two for further investigation and disciplinary action, if confirmed, with a copy to the union Chairperson with the consent of the complainant. After all steps of the Harassment Protection Policy have been exhausted, if the incident has not been resolved to the satisfaction of the employee, the employee may file a grievance at Step 2 of the grievance procedure.

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