Clinical Quality Assurance and Validation Sample Clauses

Clinical Quality Assurance and Validation. Quality Plan CQA Site Audit V. Budget A. Estimated Project Budget Services Unit # Units Unit Cost AUD Service Fees AUD Estimated Pass-Thru AUD Estimated Total Cost AUD STUDY MANAGEMENT CLINICAL TRIAL INITIATION CLINICAL TRIAL MANAGEMENT Services Unit # Units Unit Cost AUD Service Fees AUD Estimated Pass-Thru AUD Estimated Total Cost AUD MEDICAL AND SAFETY Services Unit # Units Unit Cost AUD Service Fees AUD Estimated Pass-Thru AUD Estimated Total Cost AUD CLINICAL DATA MANAGEMENT Services Unit # Units Unit Cost AUD Service Fees AUD Estimated Pass-Thru AUD Estimated Total Cost AUD Services Unit # Units Unit Cost AUD Service Fees AUD Estimated Pass-Thru AUD Estimated Total Cost AUD BIOMETRICS ANALYSIS CLINICAL WRITING REGULATORY SERVICES Services Unit # Units Unit Cost AUD Service Fees AUD Estimated Pass-Thru AUD Estimated Total Cost AUD CLINICAL QUALITY ASSURANCE MISCELLANEOUS PASS-THROUGH EXPENSES B. Payment Schedules
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Clinical Quality Assurance and Validation. Quality Plan Omnicare will develop a customised project-specific Quality Plan in partnership with Sponsor. The plan will include details such as the percentages of sites/patients/data to be audited, the timeline of audits, and the plan for generation of individual Audit Reports and Certificates. Sponsor will be requested to review and sign off on the plan and any necessary amendments to the original plan, prior to implementation. CQA Site Audit Omnicare will conduct **** site audit. The site audit will include ****% review of essential documents, including all informed consent documents and serious adverse event reporting compliance. In addition, for approximately ****% (with a minimum of ****) of subjects at the study site, CRF data will be audited against source documents with an emphasis on critical efficacy and safety data; drug accountability will also be verified for these subjects. The associated cost budgeted includes preparation and travel time, audit time, audit follow-up, and Audit Report and Audit Certificate generation. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Related to Clinical Quality Assurance and Validation

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • 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. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • Data Quality 4.1 Each party ensures that the shared Personal Data is accurate. 4.2 Parties will notify each other with undue delay if they become aware of inaccuracies in shared Personal Data.

  • Assistance and Cooperation (a) Each of the Companies shall provide (and shall cause its Affiliates to provide) the other Companies and their respective agents, including accounting firms and legal counsel, with such cooperation or information as they may reasonably request in connection with (i) preparing and filing Tax Returns, (ii) determining the liability for and amount of any Taxes due (including estimated Taxes) or the right to and amount of any refund of Taxes, (iii) examinations of Tax Returns, and (iv) any administrative or judicial proceeding in respect of Taxes assessed or proposed to be assessed. Such cooperation shall include making available, upon reasonable notice, all information and documents in their possession relating to the other Companies and their respective Affiliates as provided in Section 9. Each of the Companies shall also make available to the other Companies, as reasonably requested and available, personnel (including employees and agents of the Companies or their respective Affiliates) responsible for preparing, maintaining, and interpreting information and documents relevant to Taxes. (b) Any information or documents provided under this Section 8 or Section 9 shall be kept confidential by the Company or Companies receiving the information or documents, except as may otherwise be necessary in connection with the filing of Tax Returns or in connection with any administrative or judicial proceedings relating to Taxes. Notwithstanding any other provision of this Agreement or any other agreement, in no event shall any of the Companies or any of their respective Affiliates be required to provide the other Companies or any of their respective Affiliates or any other Person access to or copies of any information if such action could reasonably be expected to result in the waiver of any Privilege. In addition, in the event that any of the Companies determine that the provision of any information to the other Companies or their respective Affiliates could be commercially detrimental, violate any law or agreement or waive any Privilege, the Parties shall use reasonable best efforts to permit compliance with their obligations under this Section 8 or Section 9 in a manner that avoids any such harm or consequence.

  • 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.

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