Ceded Review Sample Clauses

Ceded Review. This Agreement provides for and serves as documentation of the transfer of authority to, and reliance on, a Reviewing IRB for IRB review and oversight of Research (“Ceded Review”). For purposes of this Agreement, “Research” means (i) any human subjects research within the meaning of the Federal Policy or within the meaning of any other federal human subjects protection regulations or policies; (ii) any investigation/clinical investigation within the meaning of the U.S. Food and Drug Administration (“FDA”) Clinical Investigation Regulations (defined in Exhibit A); and (iii) any other human subjects research for which any Participating Institution seeks or is required to rely on a Reviewing IRB. As used in this Agreement, Research may reference a specific study or protocol (an instance of Research) or collectively any or all of the studies or protocols eligible under the Agreement.
Sample 1
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Ceded Review. The transfer of authority to, and reliance on, a Reviewing IRB for IRB review and oversight of Research.
Sample 1
Ceded Review. This Agreement applies to:provides for and serves as documentation of the transfer of authority to, and reliance on, a Reviewing IRB for IRB review and oversight of Research (“Ceded Review”). For purposes of this Agreement, “Research” means (i) any human subjects research within the meaning of the Federal Policy or within the meaning of any other federal human subjects research protection regulations or policies; (ii) any investigation/clinical investigation within the meaning of the U.S. Food and Drug Administration (“FDA”) IRBClinical Investigation rRegulations (defined in Exhibit A); and (iii) any other human subjects research for which any Participating Institution(s) seeks or areis required to rely upon a Reviewing IRB (“Research”). As used in this Agreement, Research may reference a specific study or protocol in which there will be a Reviewing IRB and Relying Institution operating pursuant to the terms of this Agreement,(an instance of Research) or collectively any or all of the studies or protocols reviewedeligible under the Agreement.
Sample 1

Related to Ceded Review

  • 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.

  • Periodic Review The General Counsel shall periodically review the Procurement Integrity Procedures with OSC personnel in order to ascertain potential areas of exposure to improper influence and to adopt desirable revisions for more effective avoidance of improper influences.

  • Post Review With respect to each contract not governed by paragraph 2 of this Part, the procedures set forth in paragraph 4 of Appendix 1 to the Guidelines shall apply.

  • Program Review The Contracting Officer or other authorized government representative may hold semi- annual program review meetings. Such meetings will be held via telecom or video teleconferencing. However, the Government reserves the right to request a meeting in person. The meetings will include all BPA holders, representatives from prospective customer agencies, a combination of current and prospective customer agencies, or individual BPA holders. Some Federal Government Agencies and any approved State, Local and Tribal agencies may establish a central program management function. Such users may require their primary suppliers to participate in agency program review meetings on a periodic basis, at no additional cost to the Government.

  • 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.

  • Utilization Review We review health services to determine whether the services are or were Medically Necessary or experimental or investigational ("Medically Necessary"). This process is called Utilization Review. Utilization Review includes all review activities, whether they take place prior to the service being performed (Preauthorization); when the service is being performed (concurrent); or after the service is performed (retrospective). If You have any questions about the Utilization Review process, please call the number on Your ID card. The toll-free telephone number is available at least 40 hours a week with an after-hours answering machine. All determinations that services are not Medically Necessary will be made by: 1) licensed Physicians; or 2) licensed, certified, registered or credentialed health care professionals who are in the same profession and same or similar specialty as the Provider who typically manages Your medical condition or disease or provides the health care service under review. We do not compensate or provide financial incentives to Our employees or reviewers for determining that services are not Medically Necessary. We have developed guidelines and protocols to assist Us in this process. Specific guidelines and protocols are available for Your review upon request. For more information, call the number on Your ID card or visit Our website at xxx.xxxxxxx.xxx.

  • Extended Reporting Period If any required insurance coverage is on a claims-made basis (rather than occurrence), Contractor shall maintain such coverage for a period of no less than three (3) years following expiration or termination of the Master Contract.

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