Study Sponsor Monitoring on Site Sample Clauses

Study Sponsor Monitoring on Site. ‌ The study Sponsor personnel or their designee will perform study site monitoring. Each site will be monitored according to 21 CFR 812 and Pulmonx Inc. (or designee’s) internal monitoring SOPs. This will be done to ensure that the study is conducted in full compliance with all applicable regulations, and with the study protocol. A pre- investigation meeting will occur with each potential study site in order to orient the prospective Investigator and staff to the clinical trial protocol, applicable regulations and requirements, and expectations of the study, including the numbers and time frame for study participant enrollment, study participant selection, informed consent, randomization, required clinical data and record keeping. The prospective study site will be evaluated to ensure that it has an adequate patient base and can provide sufficient staff and documentation support to conduct the study properly. No study site may receive shipment of the study device components until Pulmonx receives the following documents:
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Related to Study Sponsor Monitoring on Site

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards.

  • CONTRACTING BODY SATISFACTION MONITORING 18.1 The Authority may from time to time undertake (or procure the undertaking of) a Contracting Body satisfaction survey ("Contracting Body Satisfaction Survey") the purpose of which shall include:

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • Environmental Inspection at End of Agreement Term A. At Authority’s discretion, at least one hundred and twenty (120) days before the expiration or early termination of the Term as provided herein, Company will conduct an environmental inspection and examination of the Company Premises. At its discretion, Authority may complete environmental reviews to determine if recognized environmental conditions exist that could warrant soil and groundwater sampling. If warranted by the findings of Company or Authority’s inspection or if requested by Authority, a compliance audit or site assessment will be performed within the aforementioned time period by a qualified professional acceptable to Authority who will report the findings to Authority. The cost for professional consulting or engineering services required for such audit will be at the expense of Company. If a site assessment is conducted, Company agrees to pay all associated laboratory and testing fees incurred to test and analyze samples collected during the site assessment process. The Authority may also choose to conduct the compliance audit or site assessment. If the results of the assessment indicate that the Company Premises have been impacted by the release of Hazardous Substances, Company will immediately take such action as is necessary and will provide a substantial guaranty in a form and content acceptable to Authority that Company will clean up the contamination at its own expense, at no expense to Authority, and in accordance with Applicable Laws to the extent that it is obligated to do so by virtue of the foregoing provisions of this Article.

  • Provisioning of High Frequency Spectrum and Splitter Space 3.2.1 BellSouth will provide <<customer_name>> with access to the High Frequency Spectrum as follows:

  • Access, Use, Monitoring and Inspection Site shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use. Site shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Site’s facilities and to Medical Records and Study Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. 1.3.3.

  • Program Monitoring and Evaluation (c) The Recipient shall prepare, or cause to be prepared, and furnish to the Association not later than six months after the Closing Date, a report of such scope and in such detail as the Association shall reasonably request, on the execution of the Program, the performance by the Recipient and the Association of their respective obligations under the Legal Agreements and the accomplishment of the purposes of the Financing.”

  • Project Monitoring Reporting Evaluation A. The Project Implementing Entity shall monitor and evaluate the progress of its activities under the Project and prepare Project Reports in accordance with the provisions of Section 5.08(b) of the General Conditions and on the basis of indicators agreed with the Bank. Each such report shall cover the period of one

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.

  • Implementation of and Reporting on the Project A. The Grantee shall implement and complete the Project in accordance with Exhibit A and with the plans and specifications contained in its Grant Application, which is on file with the State and is incorporated by reference. Modification of the Project shall require prior written approval of the State.

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