Study Drug Withdrawal Sample Clauses

Study Drug Withdrawal. Participation in the study is strictly voluntary. Subjects are free to discontinue the study at any time without giving their reason(s). A subject must be withdrawn from the study treatment in the event of any of the following: • Withdrawal of the subject’s consent; • New onset of a condition that would have met exclusion criterion, is clinically relevant and affects the subject’s safety, and discontinuation is considered necessary by the Investigators or Sage; • Occurrence of intolerable adverse events; • Intake of nonpermitted concomitant medication; • Subject noncompliance; • Significant protocol deviation determined in consultation with the Medical Monitor. If a subject failed to attend scheduled assessments during the course of the study, the Investigators must determine the reasons and the circumstances as completely and accurately as possible and document this in the subject’s source documents. Subjects may be withdrawn from the study if there is concern for the subject’s safety or it is determined that the subject is no longer a qualified participant. Subjects who withdraw or are withdrawn from the study will be replaced only if they withdraw prior to dosing. Subjects who are withdrawn from the study, fail to return or are no longer qualified will not be replaced.
AutoNDA by SimpleDocs

Related to Study Drug Withdrawal

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

  • 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 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.

  • How to File an Appeal of a Prescription Drug Denial For denials of a prescription drug claim based on our determination that the service was not medically necessary or appropriate, or that the service was experimental or investigational, you may request an appeal without first submitting a request for reconsideration. You or your physician may file a written or verbal prescription drug appeal with our pharmacy benefits manager (PBM). The prescription drug appeal must be submitted to us within one hundred and eighty (180) calendar days of the initial determination letter. You will receive written notification of our determination within thirty (30) calendar days from the receipt of your appeal. How to File an Expedited Appeal Your appeal may require immediate action if a delay in treatment could seriously jeopardize your health or your ability to regain maximum function, or would cause you severe pain. To request an expedited appeal of a denial related to services that have not yet been rendered (a preauthorization review) or for on-going services (a concurrent review), you or your healthcare provider should call: • our Grievance and Appeals Unit; or • our pharmacy benefits manager for a prescription drug appeal. Please see Section 9 for contact information. You will be notified of our decision no later than seventy-two (72) hours after our receipt of the request. You may not request an expedited review of covered healthcare services already received.

  • Prescription Drug Program 1. It is agreed that the State shall continue the Prescription Drug Benefit Program during the period of this Agreement. The program shall be funded and administered by the State. It shall provide benefits to all eligible unit employees and their eligible dependents. Each prescription required by competent medical authority for Federal legend drugs shall be paid for by the State from funds provided for the Program subject to a deductible provision which shall not exceed $5.00 per prescription or renewal of such prescription and further subject to specific procedural and administrative rules and regulations which are part of the Program.

  • Prescription Drug Plan Effective July 1, 2011, retail and mail order prescription drug copays for bargaining unit employees shall be as follows: Type of Drug Prescriptions for 1-45 Days (1 copay) Prescriptions for 46-90 Days (2 copays) Generic drug $10 $20 Preferred brand name drug $25 $50 Non-preferred brand name drug $40 $80 Effective July 1, 2011, for each plan year the Prescription Drug annual out-of- pocket copay maximum shall be $1,000 for individual coverage and $1,500 for employee and spouse, employee and child, or employee and family coverage.

  • Distribution Protocol (1) At a time wholly within the discretion of Class Counsel, but on notice to the Settling Defendants, Class Counsel will bring motions seeking orders from the Courts approving the Distribution Protocol. The motions can be brought before the Effective Date, but the orders approving the Distribution Protocol shall be conditional on the Effective Date occurring.

  • 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.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!