Study Discontinuation Sample Clauses

Study Discontinuation. The study may be discontinued at any time by the pharmaceutical supporters, local ministry of health, the IRB or EC, the OHRP, the NIAID, or other government agencies as part of their duties to ensure that research participants are protected. PUBLICATION OF RESEARCH FINDINGS Publication of the results of this trial will be governed by ACTG policies. Any presentation, abstract, or manuscript will be made available for review by the pharmaceutical supporters prior to submission. BIOHAZARD CONTAINMENT As the transmission of HIV and other blood-borne pathogens can occur through contact with contaminated needles, blood, and blood products, appropriate blood and secretion precautions will be employed by all personnel in the drawing of blood and shipping and handling of all specimens for this study, as currently recommended by the Centers for Disease Control and Prevention and the National Institutes of Health. All dangerous goods materials, including diagnostic specimens and infectious substances, must be transported according to the instructions detailed in the International Air Transport Association (IATA) Dangerous Goods Regulations.
Sample 1
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Study Discontinuation. This study may be terminated by Sydney Retina Clinic or Novartis Australia Ltd at any time. Reasons for terminating the study may include the following: The incidence or severity of adverse events in this or other studies indicates a potential health hazard to subjects Subject enrolment is unsatisfactory Data recording is inaccurate or incomplete
Sample 1
Study Discontinuation. If the Sponsor, the Investigator, the medical monitor, the study monitor, institutional review board/independent ethics committee(s) (IRB/IEC), or appropriate regulatory officials discover conditions arising during the study that indicate the study should be halted or that the study center should be terminated, appropriate action may be taken after consultation among (at a minimum) the Sponsor, the Investigator, IRB/IEC and the medical monitor. Conditions that may warrant termination of the study or an individual site include, but are not limited to, the following: • The discovery of an unexpected, serious, or unacceptable risk to patients enrolled in the study • A decision by the Sponsor to suspend or discontinue testing, evaluation, or development of the product • Failure of the Investigator to enroll patients into the study at an acceptable rate • Failure of the Investigator to comply with pertinent regulations of IRB/IEC or appropriate regulatory authorities • Failure of the Investigator to comply with the protocol • Submission of knowingly false information from the research facility to the Sponsor, the study monitor, IRB/IEC or regulatory authority • Insufficient adherence to protocol requirements consistent with 21 CFR 312 or the European Clinical Trial Directive 2001/20/EC Study termination and follow-up will be performed in compliance with the conditions set forth in International Conference on Harmonisation (ICH) E6 on Good Clinical Practice (GCP) as well as 21 CFR 312.56b and the European Clinical Trial Directive 2001/20/EC which require a Sponsor to ensure an Investigator’s compliance with these requirements and to promptly secure a plan for compliance or discontinue shipments of the IP to the Investigator and end the Investigator’s participation in the study.
Sample 1

Related to Study Discontinuation

  • Discontinuation Either party may discontinue the job/time sharing arrangement with ninety

  • Continuation of or Change in Business Each of the Loan Parties shall not, and shall not permit any of its Unregulated Subsidiaries to, engage in any business other than a Permitted Business.

  • Benefits Continuation In addition, Executive shall be entitled to health and dental insurance benefits for a period of eighteen (18) months following the termination of this Agreement. These benefits will be provided at Employer’s expense, but such period shall count towards the Employer’s continuation of coverage obligation under Section 4980B of the Internal Revenue Code (commonly referred to as “COBRA”).

  • Presentation of Potential Target Businesses The Company shall cause each of the Initial Shareholders to agree that, in order to minimize potential conflicts of interest which may arise from multiple affiliations, the Initial Shareholders will present to the Company for its consideration, prior to presentation to any other person or company, any suitable opportunity to acquire an operating business, until the earlier of the consummation by the Company of a Business Combination or the liquidation of the Company, subject to any pre-existing fiduciary obligations the Initial Shareholders might have.

  • Continuation of Health Benefits An employee on an approved Military Caregiver Leave shall be entitled to continue participation in health plan coverage (medical, dental, and optical) as if on pay status during the leave.

  • Continuation of Work Pending the resolution of any dispute or claim pursuant to this Article 11, the Parties agree that performance of all obligations will be pursued diligently.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • 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.

  • Continuation of Business Neither the Transfer of any Partnership Interest pursuant to Article 8 hereof nor the bankruptcy or withdrawal of a Partner shall cause the dissolution or termination of the Partnership or have any effect upon the continuance of the Partnership business. No Partner shall have a right to withdraw from the Partnership or to abandon any Partnership Interest.

  • CONTINUATION OF COMPANY In the event of an occurrence described in Section 1.04, if there is at least (1) one remaining Member, the remaining Member has the right to continue the business of the Company. The remaining Member’s successor, assignee, or transferee may continue the business of the Company, provided the successor, assignee, or transferee consents to the continuation in writing and submits any necessary filings to the office of the Secretary of State.

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