IRB Review Sample Clauses

IRB Review. Reviewing IRB Institution represents and warrants that, without limitation of its review obligations set forth in Section 5.4 of the SMART Agreement, it will, in its review and oversight of the Study, take into consideration, account for and (This space has been intentionally left blank.) comply with applicable State and local laws, rules and regulations.
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IRB Review. An appropriate University IRB designated under the University’s Federal-Wide Assurance, in accordance with U.S. Department of Health and Human Services regulations and Office for Human Research Protections administrative guidance, will be the IRB of record for the study. For the avoidance of doubt, such University IRB shall not be the IRB of record for any research conducted at or by the Facility other than the study conducted pursuant to this Agreement. The Facility will abide by all determinations of such University IRB (including the use of informed consent forms reviewed and approved by and on file with the University IRB) and will accept the final authority and decisions of such University IRB, including but not limited to directives to terminate participation in designated research activities. Consider provision whereby University is compensated for sending representatives to monitor study under local conditions (OHRP requirement to monitor study).
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IRB Review. Mathematica has received IRB approval from Health Media Labs for the Evaluation’s research protocol. Mathematica will seek IRB approval by the College’s own IRB, as applicable.
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IRB Review. The HRPP of the Receiving IRB performs a pre-review, following standard local procedures, before accepting responsibility for the protocol(s). The HRPP of the Receiving IRB may request the investigator to provide additional information or the Original IRB to provide local context information to the Receiving IRB. The Receiving IRB performs a complete review of the protocol(s), following standard procedures and using the relevant criteria for IRB approval. This may include the requirement for modifications or consent form changes. The Receiving IRB establishes a new approval period, including the frequency of continuing review.
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Related to IRB Review

  • 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.

  • 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.

  • 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.

  • Validation Review In the event OIG has reason to believe that: (a) Good Shepherd’s Claims Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the Claims Review complied with the requirements of the CIA and/or the findings or Claims Review results are inaccurate (Validation Review). Good Shepherd shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as part of Good Shepherd’s final Annual Report shall be initiated no later than one year after Good Shepherd’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Good Shepherd of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Good Shepherd may request a meeting with OIG to: (a) discuss the results of any Claims Review submissions or findings; (b) present any additional information to clarify the results of the Claims Review or to correct the inaccuracy of the Claims Review; and/or (c) propose alternatives to the proposed Validation Review. Good Shepherd agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any Claims Review issues with Good Shepherd prior to conducting a Validation Review. However, the final determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG.

  • 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.

  • Position Review ‌ The Employer may initiate a position review for a position it believes is improperly classified, and will inform the Union in writing when it has initiated a reallocation process for a bargaining unit position. An individual employee who believes that their position is improperly classified may request a review according to the following procedure:

  • 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.

  • 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.

  • Project Review A. Programmatic Allowances

  • Periodic Reviews During January of each year during the term hereof, the Board of Directors of the Company shall review Executive's Annual Salary, bonus, stock options, and additional benefits then being provided to Executive. Following each such review, the Company may in its discretion increase the Annual Salary, bonus, stock options, and benefits; however, the Company shall not decrease such items during the period Executive serves as an employee of the Company. Prior to November 30th of each year during the term hereof, the Board of Directors of the Company shall communicate in writing the results of such review to Executive.

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