Study Review Sample Clauses

The Study Review clause establishes the process and criteria for evaluating the progress, results, or conduct of a study during its course. Typically, this clause outlines who is responsible for conducting the review, the frequency or timing of such reviews, and the specific aspects of the study that will be assessed, such as data integrity, compliance with protocols, or participant safety. By formalizing the review process, this clause ensures ongoing oversight and quality control, helping to identify and address issues early and maintain the study’s integrity.
Study Review. KFSH&RC shall conduct the Study at the KFSH&RC facilities with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. KFSH&RC shall provide SPONSOR with written evidence of review and approval of this Study by KFSH&RC Institutional Review Board (“IRB”) prior to the initiation of the Study and shall inform SPONSOR of the IRB’s continuing review promptly after such a review takes place, which shall be at least once per year.
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Study Review. Research conducted by the Principal Investigator at General shall be with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. Principal Investigator shall, when applicable, provide Palomar with written evidence of review and approval of Clinical Studies prior to initiation of the Clinical Studies and shall inform Palomar of the IRB’s continuing review promptly after such review takes place, which shall be at least once per year. All volunteers shall meet the legal age requirements of the Commonwealth of Massachusetts, the state in which the Research is to be conducted. In the performance of this Agreement, General agrees not to provide Palomar with any patient identifying information. Recognizing a common goal of securing the integrity of all individually identifiable health information, the parties agree to treat as confidential all individually identifiable health information in accordance with all applicable federal, state and local laws, rules and regulations governing the confidentiality and privacy of individually identifiable health information, including, but without limitation, to the extent that each party is subject to it, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and any regulations and official guidance promulgated thereunder. Palomar further agrees, at all times, to regard and preserve as confidential such individually identifiable health information, and to refrain from publishing or disclosing any part of such individually identifiable health information or from using it, except as necessary to discuss and analyze the results of the study, to ensure research integrity, to communicate with the Food and Drug Administration and other regulatory authorities, and otherwise as required by law or as permitted by authorizations or consents signed by study subjects or waivers of authorization granted by an IRB overseeing the study or General’s affiliated Privacy Board (the “Permitted Activities”). Palomar also agrees to restrict the use and disclosure of any individually identifiable health information gained through the Permitted Activities to its workforce, contractors, subcontractors, study collaborators and agents (collectively “Recipients of Patient Information”) who must have access to that information in order directly to support or facilitate the Permitted Activities; and to notify the Rec...
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Study Review. Principal Investigator shall conduct the Study at General with the prior approval and ongoing review, of all appropriate and necessary review authorities and in accordance with all applicable federal, state, and local laws. and regulations. Principal Investigator shall provide Company with written evidence of review and approval of this Study by General's Institutional Review Board ("IRB") prior to the initiation of the Study and shall inform Company of the IRB's continuing review promptly after such review takes place, which shall be at least once per year. All volunteers shall meet the legal age requirements of the Commonwealth of Massachusetts, the state in which the Study is to be conducted.
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Study Review. DFPCC shall conduct the Study with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. Principal Investigator shall provide Company with written evidence of review and approval of this Study by DFPCC's Institutional Review Board ("IRB") prior to the initiation of the Study and shall inform Company of the IRB's continuing review and approval of the Study promptly after such review takes place, which shall be at least once per year.
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Study Review. Both cities shall have the opportunity to participate in the Feasibility Study review and provide comments on all deliverables. The cities agree to conduct the reviews and provide comments in a timely manner to assist the consultant in completing the Feasibility Study on the timeline designated in the contract.
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Study Review. The Study shall be conducted by staff members of Institution under the direction of the Principal Investigator at Institution or elsewhere with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. The Study may also be subcontracted to other sites which have been approved by deCODE ("Approved Subcontractee"), provided that any such Approved Subcontractee agrees in writing to be bound by the terms of this Agreement. Principal Investigator shall provide deCODE with written evidence of review and approval of this Study by Institution's Institutional Review Board ("IRB") prior to the initiation of the Study and shall inform deCODE of the IRB's continuing review promptly after such review takes place, which shall be at least once per year.
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Study Review. The PI shall conduct the STUDY at the KFSH&RC facilities with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable local laws and regulations. PI shall obtain approval of this STUDY from the KFSH&RC Research Ethics Committee (“REC”) prior to initiation of the STUDY. Written evidence of review and approval of the STUDY by the KFSH&RC REC shall be maintained by PI and be made available to the Kingdom of Saudi Arabia’s Food and Drug Authority upon request. Continuing review by REC shall take place at least once per year, and documentation of continuing approval shall be maintained by PI.
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Related to Study Review

  • Program Review The State ECEAP Office will conduct a review of each contractor’s compliance with the ECEAP Contract and ECEAP Performance Standards every four years. The review will involve ECEAP staff and parents. After the Program Review, the State ECEAP Office will provide the contractor with a Program Review report. The contractor must submit an ECEAP Corrective Action Plan for non-compliance with ECEAP Performance Standards. The Plan must be approved by the State ECEAP Office.

  • 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.

  • Project Review A. Programmatic Allowances 1. If FEMA determines that the entire scope of an Undertaking conforms to one or more allowances in Appendix B of this Agreement, with determinations for Tier II Allowances being made by SOI-qualified staff, FEMA shall complete the Section 106 review process by documenting this determination in the project file, without SHPO review or notification. 2. If the Undertaking involves a National Historic Landmark (NHL), FEMA shall notify the SHPO, participating Tribe(s), and the NPS NHL Program Manager of the NPS Midwest Regional Office that the Undertaking conforms to one or more allowances. FEMA shall provide information about the proposed scope of work for the Undertaking and the allowance(s) enabling FEMA’s determination. 3. If FEMA determines any portion of an Undertaking’s scope of work does not conform to one or more allowances listed in Appendix B, FEMA shall conduct expedited or standard Section 106 review, as appropriate, for the entire Undertaking in accordance with Stipulation II.B, Expedited Review for Emergency Undertakings, or Stipulation II.C, Standard Project Review. 4. Allowances may be revised and new allowances may be added to this Agreement in accordance with Stipulation IV.A.3, Amendments. B. Expedited Review for Emergency Undertakings

  • Independent Review Contractor shall provide the Secretary of ADS/CIO an independent expert review of any Agency recommendation for any information technology activity when its total cost is $1,000,000.00 or greater or when CIO requires one. The State has identified two sub-categories for Independent Reviews, Standard and Complex. The State will identify in the SOW RFP the sub-category they are seeking. State shall not consider bids greater than the maximum value indicated below for this category. Standard Independent Review $25,000 Maximum Complex Independent Review $50,000 Maximum Per Vermont statute 3 V.S.A. 2222, The Secretary of Administration shall obtain independent expert review of any recommendation for any information technology initiated after July 1, 1996, as information technology activity is defined by subdivision (a) (10), when its total cost is $1,000,000 or greater or when required by the State Chief Information Officer. Documentation of this independent review shall be included when plans are submitted for review pursuant to subdivisions (a)(9) and (10) of this section. The independent review shall include: • An acquisition cost assessment • A technology architecture review • An implementation plan assessment • A cost analysis and model for benefit analysis • A procurement negotiation advisory services contract • An impact analysis on net operating costs for the agency carrying out the activity In addition, from time to time special reviews of the advisability and feasibility of certain types of IT strategies may be required. Following are Requirements and Capabilities for this Service: • Identify acquisition and lifecycle costs; • Assess wide area network (WAN) and/or local area network (LAN) impact; • Assess risks and/or review technical risk assessments of an IT project including security, data classification(s), subsystem designs, architectures, and computer systems in terms of their impact on costs, benefits, schedule and technical performance; • Assess, evaluate and critically review implementation plans, e.g.: • Adequacy of support for conversion and implementation activities • Adequacy of department and partner staff to provide Project Management • Adequacy of planned testing procedures • Acceptance/readiness of staff • Schedule soundness • Adequacy of training pre and post project • Assess proposed technical architecture to validate conformance to the State’s “strategic direction.” • Insure system use toolsets and strategies are consistent with State Chief Information Officer (CIO) policies, including security and digital records management; • Assess the architecture of the proposed hardware and software with regard to security and systems integration with other applications within the Department, and within the Agency, and existing or planned Enterprise Applications; • Perform cost and schedule risk assessments to support various alternatives to meet mission need, recommend alternative courses of action when one or more interdependent segment(s) or phase(s) experience a delay, and recommend opportunities for new technology insertions; • Assess the architecture of the proposed hardware and software with regard to the state of the art in this technology. • Assess a project’s backup/recovery strategy and the project’s disaster recovery plans for adequacy and conformance to State policy. • Evaluate the ability of a proposed solution to meet the needs for which the solution has been proposed, define the ability of the operational and user staff to integrate this solution into their work.

  • Log Reviews All systems processing and/or storing PHI COUNTY discloses to 11 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY 12 must have a routine procedure in place to review system logs for unauthorized access.