Study and Site Closure Sample Clauses

Study and Site Closure. ‌‌‌ The Sponsor designee reserves the right to close the study site or terminate the study at any time for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study completion. A study site is considered closed when all required documents and study supplies have been collected, and a study-site closure visit has been performed. The Investigator may initiate study-site closure at any time, provided there is reasonable cause and sufficient notice is given in advance of the intended termination. Reasons for the early closure of a study site by the Sponsor or Investigator may include but are not limited to: • Failure of the Investigator to comply with the protocol, the requirements of the IRB/IEC/REB or local health authorities, the Sponsor’s procedures, or GCP guidelines • Inadequate recruitment of subjects by the Investigator • Discontinuation of further study drug development
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Study and Site Closure. Upon completion of the study, the following activities, when applicable, must be conducted by the monitor in conjunction with the investigator, as appropriate: • Return of all study data to Glaxo Wellcome. • Data clarifications and/or resolutions. • Accounting, reconciliation, and final disposition of used and unused study drugs. • Review of site study records for completeness. In addition, GW reserves the right to temporarily suspend or prematurely discontinue this study either at a single site or at all sites at any time and for any reason. If such action is taken, GW will discuss this with the Investigator (including the reasons for taking such action) at that time. GW will promptly inform all other investigators and/or institutions conducting the study if the study is suspended or terminated for safety reasons, and will also inform the regulatory authorities of the suspension or termination of the study and the reason(s) for the action. If required by applicable regulations, the investigator must inform the IRB or IEC promptly and provide the reason for the suspension or termination. If the study is prematurely discontinued, all study data must be returned to GW. In addition, the site must conduct final disposition of all unused study drugs in accordance with GW procedures for the study. Financial compensation to investigators and/or institutions will be in accordance with the agreement established between the investigator and GW.
Study and Site Closure. The sponsor designee reserves the right to close the study site (decentralized) or terminate the study at any time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A study site is considered closed when all required documents and study supplies have been collected and a study-site closure visit has been performed. The investigator may initiate study-site closure at any time, provided there is reasonable cause and sufficient notice is given in advance of the intended termination. Reasons for the early closure of a study site by the sponsor or investigator may include but are not limited to: ● Failure of the investigator to comply with the protocol, the requirements of the IRB or local health authorities, the sponsor's procedures, or GCP guidelines ● Inadequate recruitment of participants by the investigator

Related to Study and Site Closure

  • Contract Closure Contracting Officer shall give appropriate written notice to Purchaser when Purchaser has complied with the terms of this contract. Purchaser shall be paid refunds due from Timber Sale Account un- der B4.24 and excess cooperative deposits under B4.218.

  • PLANT CLOSURE 29.01 In the event the Company closes the plant at the Cambridge location as a result of the loss of business or a discontinuation of all operations, severance pay will be calculated at one (1) week’s regular pay per year of service. The severance payment, so calculated, is inclusive of any severance payment required by the Ontario Employment Standards Act (Revised 2000). This agreement is not applicable to a sale of the business or if the closure is occasioned by a labour dispute.

  • Off-Site Environmental Impacts Nothing in this Article will be construed to make Company liable in any way for any environmental impacts or release of Hazardous Substances affecting the Company Premises that occurs by reason of the migration or flow to the Company Premises from verifiable or documented off-site environmental impacts that is not attributable to Company’s activities at the Company Premises.

  • Notice to Proceed - Site Improvements The Recipient shall not commence, or cause to be commenced, any site improvements or other work on the Land until the Director has issued a Notice to Proceed to the Recipient. Such Notice to Proceed will not be issued until the Director is assured that the Recipient has complied with all requirements for the approval of a grant under Revised Code Sections 164.20 through 164.27 and has completed any land acquisition required by the Project. A Notice to Proceed shall be required for all Project prime contractors or direct procurement initiated by the Recipient following execution of this Agreement.

  • Prior Environmental Impacts Nothing in this Article will be construed to make Company liable in any way for any environmental impacts or release of Hazardous Substances affecting the Company Premises that occurred prior to Company’s entry upon the Company Premises or that occurred as a result of the actions of Authority or any of its employees, agents, or contractors.

  • Access to Project Site Redeveloper shall permit the representatives of the City to enter Project Site at any and all reasonable times, as the City may deem necessary for the purposes of this Redevelopment Agreement, including but not limited to work and inspection of all work being performed in connection with the construction of the Redeveloper Improvements. Similarly, the City shall permit Redeveloper such entry upon the public rights of way for such purposes. No compensation shall be payable nor shall any charges be made in any form by any party for the access or inspection provided for in this Section. The City’s right of access granted under this Section shall terminate upon issuance by the City of the Redeveloper’s Certificate of Completion of Redeveloper Improvements. Notwithstanding the above, Redeveloper shall not be relieved of the provisions contained in Chapter 14.29 of the Lincoln Municipal Code regarding the use of streets for private construction purposes.

  • Time Clocks The Employer shall not add time clocks, unless the Union has been served notice and the Agency has engaged in discussions with the Union. During the term of this Agreement, upon request of either party, the parties agree to establish a joint Labor/Management Committee for the purpose of examining the impact of an automated State payroll system upon this Agreement and developing recommendations for the implementation of such a system.

  • Construction Documents Phase Services 3.4.1 Based on the Owner’s approval of the Design Development Documents, and on the Owner’s authorization of any adjustments in the Project requirements and the budget for the Cost of the Work, the Architect shall prepare Construction Documents for the Owner’s approval. The Construction Documents shall illustrate and describe the further development of the approved Design Development Documents and shall consist of Drawings and Specifications setting forth in detail the quality levels and performance criteria of materials and systems and other requirements for the construction of the Work. The Owner and Architect acknowledge that, in order to perform the Work, the Contractor will provide additional information, including Shop Drawings, Product Data, Samples and other similar submittals, which the Architect shall review in accordance with Section 3.6.4.

  • Project Closeout a. Participate in final inspection to prepare punch lists for project contractor to correct and/or to complete listed items. Verify that items on punch lists have been completed successfully assist COUNTY Project Manager or designee to determine completion date and coordinate project close out.

  • School Closure The School shall make reasonable efforts to promptly notify the public, which may include notice to the Department of Education, of any circumstance requiring the closure of the School, including, but not limited to, a natural disaster, such as an earthquake, storm, tsunami, flood, or other weather-related event, other extraordinary emergency, or destruction of or damage to the School facility;

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