STUDY GOVERNANCE Sample Clauses

STUDY GOVERNANCE. The Parties agree to comply with all relevant laws, regulations and codes of practice applicable to this Agreement including to the performance of the Study. The Parties agree to comply with the following relevant guidance: The World Medical Association Declaration of Helsinki, titled “Ethical Principles for Medical Research Involving Human Subjects”. The Research Governance Framework for Health and Social Care, Second Edition, April 2005, or the Research Governance Framework for Health and Social Care in Wales, November 2001 or the Scottish Executive Health Department Research Governance Framework for Health and Community Care, Second Edition, February 2006 or the Research Governance Framework for Health and Social Care in Northern Ireland, December 2006 or the latest version of the relevant Research Governance Framework should it be revised and reissued. Should there be any inconsistency between the Protocol and the other terms of this Agreement, or any document incorporated therein, the terms of the Protocol shall prevail to the extent of such inconsistency except insofar as the consistency relates to clauses 4, 5, 7 and/or 8 of this Agreement where these terms of the Agreement shall prevail.
STUDY GOVERNANCE. 10.2.1 Data Quality Assurance
STUDY GOVERNANCE. 1. STUDY; IRB; PROTOCOL CHANGES a. INSTITUTION shall, and shall ensure that all Study Personnel, conduct the Study under the review of an IRB (as defined below) and in accordance with (i) the Protocol, (ii) this Agreement, (iii) all applicable laws, rules, regulations, good clinical practices, current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use/Good Clinical Practice (“ICH-GCP”) guidelines and the requirements and official guidance of relevant health authorities (collectively, as the same may be amended from time to time, “Applicable Law”), and (iv) any other written instructions or requirements provided by SPONSOR or CRO. b. INVESTIGATOR shall, where required by Applicable Law, submit the Protocol, informed consent form, written authorization described in Section 5.1(b), and advertising materials used to recruit Study subjects for review and approval to an IRB. No Study-related procedures under the Protocol may begin until such IRB and Sponsor approval and Subject consent has been obtained. “IRB” means (i) in the case of all U.S. studies and any Investigational New Drug (“IND”) study, an appropriate Human Subject Institutional Review Board or equivalent body under Applicable Law; or (ii) in the case of a non-U.S. study and any non-IND study, to an appropriate independent review committee of scientists or other qualified individuals under Applicable Law.
STUDY GOVERNANCE. The Parties agree to comply with all relevant laws, regulations and codes of practice applicable to this Agreement including the performance of the Study. The Parties agree to comply with the following relevant guidance: The World Medical Association Declaration of Helsinki, 1996 titled “Ethical Principles for Medical Research Involving Human Subjects”. The Research Governance Framework for Health and Social Care, Second Edition, April 2005 or the latest version should it be revised and reissued. Should there be any inconsistency between the Protocol and the other terms of this Agreement, or any document incorporated therein, the terms of the Protocol shall prevail to the extent of such inconsistency except insofar as the inconsistency relates to Clauses 6,7,9 and 10 of this Agreement where these terms of the Agreement shall prevail.
STUDY GOVERNANCE. 3.1 The Parties shall comply with all the Applicable Laws and Regulations. 3.2 The Institution acknowledges, that the realization of this Agreement is conditional

Related to STUDY GOVERNANCE

  • Corporate Governance The Organisation must ensure services are delivered in a manner consistent with the NSW Health Corporate Governance and Accountability Compendium.

  • Governance (a) The HSP represents, warrants and covenants that it has established, and will maintain for the period during which this Agreement is in effect, policies and procedures: that set out a code of conduct for, and that identify the ethical responsibilities for all persons at all levels of the HSP’s organization; to ensure the ongoing effective functioning of the HSP; for effective and appropriate decision-making; for effective and prudent risk-management, including the identification and management of potential, actual and perceived conflicts of interest; for the prudent and effective management of the Funding; to monitor and ensure the accurate and timely fulfillment of the HSP’s obligations under this Agreement and compliance with the Enabling Legislation; to enable the preparation, approval and delivery of all Reports; to address complaints about the provision of Services, the management or governance of the HSP; and to deal with such other matters as the HSP considers necessary to ensure that the HSP carries out its obligations under this Agreement. (b) The HSP represents and warrants that: it has, or will have within 60 Days of the execution of this Agreement, a Performance Agreement with its CEO that ties a reasonable portion of the CEO’s compensation plan to the CEO’s performance; it will take all reasonable care to ensure that its CEO complies with the Performance Agreement; it will enforce the HSP’s rights under the Performance Agreement; and a reasonable portion of any compensation award provided to the CEO during the term of this Agreement will be pursuant to an evaluation of the CEO’s performance under the Performance Agreement and the CEO’s achievement of performance goals and performance improvement targets and in compliance with Applicable Law. “compensation award”, for the purposes of Section 9.3(b)(4) above, means all forms of payment, benefits and perquisites paid or provided, directly or indirectly, to or for the benefit of a CEO who performs duties and functions that entitle him or her to be paid.

  • Ethics No officer, agent or employee of the Board is or shall be employed by Provider or has or shall have a financial interest, directly or indirectly, in this Agreement or the compensation to be paid hereunder except as may be permitted in writing by the Board’s Code of Ethics, adopted May 25, 2011 (11-0525-PO2), as amended from time to time, which policy is hereby incorporated by reference into and made part of this Agreement as if fully set forth herein.