Study Objectives definition

Study Objectives. The primary objectives are to evaluate the safety and efficacy of VI-0521 (PHEN/TPM 7.5 mg/46 mg and PHEN/TPM 15 mg/92 mg doses) for the treatment of obesity in adolescents. The secondary objective is to characterize changes in obesity- related risk factors. Duration of Treatment: The treatment period will be 56 weeks. Sample Size: Approximately 200 subjects Number of Sites/Locations: Approximately 20 sites in the United States Study Population: Key Inclusion Criteria (see Section 7.1 for a complete list): • Aged ≥ 12 years and < 17 years at the time of screening; • BMI ≥ the 95th percentile, with documented history of failure to lose sufficient weight or failure to maintain weight loss in a lifestyle modification program; • If female, must be using adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.
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Study Objectives mean a series of questions approved by the SCC Leads, to be researched and analyzed by the Contractor and described in a Report.
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Study Objectives. The primary objective is to evaluate the efficacy of KTE-X19, as measured by objective response rate (XXX), in subjects with r/r MCL. Secondary objectives will include assessing the safety and tolerability of KTE-X19, additional efficacy endpoints, and change in the European Quality of Life-5 Dimensions (EQ-5D) scores from baseline to Month 6.
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Examples of Study Objectives in a sentence

  • The British Childhood Cancer Survivor Study: Objectives, methods, population structure, response rates and initial descriptive information.

  • Dose-ranging Study: Objectives of this study include the identification of target organ of toxicity and establishment of MTD for subsequent studies.

  • When?OrganizationOpen source software (OSS) Open Innovation Figure 1: Study Objectives in the intersection between proprietary organizations and open source software.

  • Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study: Objectives, Methods, and Cohort Description.

  • The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions.

  • Scan Study Objectives ■Read Feature Story ■Read Preview ■Read text and answer DO IT!p.

  • Scan Study Objectives ■Read Feature Story ■Read Preview ■Read text and answer DO IT! p.

  • Introduction and Study Objectives 11.1 Methodology 11.2 Activities Carried Out 22.

  • If your research does not involve any of the methods listed below, ensure that your proposed research is adequately described in Section 2.1: Study Objectives and Design or attach documents in the Documentation Section if necessary.

  • Source Protection Zones within Bromsgrove District and Redditch Borough EXECUTIVE SUMMARY Study Objectives This Water Cycle Strategy (WCS) for the Bromsgrove District Council and Redditch Borough Council (the Councils) assesses the constraints and requirements that will arise from the scale of proposed growth on the water infrastructure of the Borough and District.


More Definitions of Study Objectives

Study Objectives. To evaluate epoch by epoch agreement in sleep stage assignment between scorers from different laboratories. Design: N/A Methods: 62 NPSGs were selected for analysis from 3 sleep centers (38 diagnostic studies for sleep disordered breathing [SDB], 10 studies during CPAP titration, and 14 studies in subjects with no sleep related complaints or sleep pathology). The sleep record- ing montage consisted of at least 2 EEG leads, left and right EOG and a submental EMG. Scoring was performed manually by 5 experienced sleep technologists. No scorer had knowledge of any other scorers’ results. Agreement was tabulated both for sleep stage distribution and on an epoch by epoch basis for the entire data set and the normal and SDB subsets.
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Study Objectives. To monitor the long-term safety profile of NI-0501 • To assess HLH patients’ survival after NI-0501 treatment • To assess duration of response to NI-0501 treatment (i.e. maintenance of HLH control) • To assess post-HSCT outcome measures, if applicable • To assess background disease activity, in patients with secondary forms of HLH • To study the elimination profile of NI-0501 • To evaluate the pharmacodynamic (PD) effects (levels of circulating Total IFNγ, CXCL9, CXCL10) • To assess the profile of relevant HLH biomarkers, e.g., sCD25 • To assess the immunogenicity of NI-0501
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Related to Study Objectives

  • Cost objective means a function, organizational subdivision, contract, grant, or other activity for which cost data are needed and for which costs are incurred.

  • Goals means the annual level of participation by SBEs in City Contracts as established in this chapter, the SBE Regulations, or as necessary to comply with applicable federal and state nondiscrimination laws and regulations. Goals for individual Contracts may be adjusted as provided for in this chapter and shall not be construed as a minimum for any particular Contract or for any particular geographical area.

  • Objectives means a specific statement of planned accomplishments or results that are specific, measurable, attainable, realistic, and time-limited.

  • Plan Objective means the objective of securing the return described in the brochure to which these Terms and Conditions are attached.

  • Goal means the intended or projected result of a comprehensive corrections plan or community corrections program to reduce prison commitment rates, to reduce the length of stay in a jail, or to improve the utilization of a jail.

  • Performance Objectives means the performance objective or objectives established by the Committee pursuant to the Plan. Any Performance Objectives may relate to the performance of the Company or one or more of its Subsidiaries, divisions, departments, units, functions, partnerships, joint ventures or minority investments, product lines or products, or the performance of the individual Participant, and may include, without limitation, the Performance Objectives set forth in Section 13(b). The Performance Objectives may be made relative to the performance of a group of comparable companies, or published or special index that the Committee, in its sole discretion, deems appropriate, or the Company may select Performance Objectives as compared to various stock market indices. Performance Objectives may be stated as a combination of the listed factors.

  • Targets means pre-agreed values to be achieved at the end of the period in relation to the result indicators included under a specific objective;

  • Performance Targets means the specific objective goal or goals (which may be cumulative and/or alternative) that are timely set in writing by the Committee for each Executive for the Performance Period in respect of any one or more of the Business Criteria.

  • Performance Objective means a standard established by the Committee to determine in whole or in part whether a Performance Award shall be earned.

  • Student growth objective means an academic goal that teachers and designated supervisors set for groups of students.

  • Evaluation Criteria means the criteria set out under the clause 27 (Evaluation Process) of this Part C, which includes the Qualifying Criteria, Functional Criteria and Price and Preferential Points Assessment.

  • Review Criteria has the meaning assigned to that term in Section 12.02(b)(i).

  • Management Objectives means the measurable performance objective or objectives established pursuant to this Plan for Participants who have received grants of Performance Shares or Performance Units or, when so determined by the Board, Option Rights, Appreciation Rights, Restricted Shares and dividend credits pursuant to this Plan. Management Objectives may be described in terms of Company-wide objectives or objectives that are related to the performance of the individual Participant or of the Subsidiary, division, department, region or function within the Company or Subsidiary in which the Participant is employed. The Management Objectives may be made relative to the performance of other corporations. The Management Objectives applicable to any award to a Covered Employee shall be based on specified levels of or growth in one or more of the following criteria:

  • ASAM criteria means the most current edition of the American Society of Addiction Medicine's published criteria for admission to treatment, continued services, and discharge.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Individual Objectives means as to a Participant, the objective and measurable goals set by a “management by objectives” process and approved by the Committee (in its discretion).

  • Performance Goals means, for a Performance Period, the one or more goals established by the Board for the Performance Period based upon the Performance Criteria. Performance Goals may be based on a Company-wide basis, with respect to one or more business units, divisions, Affiliates, or business segments, and in either absolute terms or relative to the performance of one or more comparable companies or the performance of one or more relevant indices. Unless specified otherwise by the Board (i) in the Award Agreement at the time the Award is granted or (ii) in such other document setting forth the Performance Goals at the time the Performance Goals are established, the Board will appropriately make adjustments in the method of calculating the attainment of Performance Goals for a Performance Period as follows: (1) to exclude restructuring and/or other nonrecurring charges; (2) to exclude exchange rate effects; (3) to exclude the effects of changes to generally accepted accounting principles; (4) to exclude the effects of any statutory adjustments to corporate tax rates; (5) to exclude the effects of any “extraordinary items” as determined under generally accepted accounting principles; (6) to exclude the dilutive effects of acquisitions or joint ventures; (7) to assume that any business divested by the Company achieved performance objectives at targeted levels during the balance of a Performance Period following such divestiture; (8) to exclude the effect of any change in the outstanding shares of common stock of the Company by reason of any stock dividend or split, stock repurchase, reorganization, recapitalization, merger, consolidation, spin-off, combination or exchange of shares or other similar corporate change, or any distributions to common stockholders other than regular cash dividends; (9) to exclude the effects of stock based compensation and the award of bonuses under the Company’s bonus plans; (10) to exclude costs incurred in connection with potential acquisitions or divestitures that are required to expensed under generally accepted accounting principles; (11) to exclude the goodwill and intangible asset impairment charges that are required to be recorded under generally accepted accounting principles and (12) to exclude the effect of any other unusual, non-recurring gain or loss or other extraordinary item. In addition, the Board retains the discretion to reduce or eliminate the compensation or economic benefit due upon attainment of Performance Goals and to define the manner of calculating the Performance Criteria it selects to use for such Performance Period. Partial achievement of the specified criteria may result in the payment or vesting corresponding to the degree of achievement as specified in the Stock Award Agreement or the written terms of a Performance Cash Award.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Performance Criteria means the criteria (and adjustments) that the Committee selects for an Award for purposes of establishing the Performance Goal or Performance Goals for a Performance Period, determined as follows:

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Timelines means the dates set out in Appendix 2 hereto as may be amended by agreement between the Parties and Timeline shall mean any one of such dates.

  • Acceptance Criteria means the Specifications, goals, performance measures, testing results and/or other criteria designated by the Agency and against which the Deliverables may be evaluated for purposes of Acceptance or Non-acceptance thereof.

  • Performance Indicator means a measure of HSP performance for which a Performance Target is set; technical specifications of specific Performance Indicators can be found in the MSAA Indicator Technical Specifications document;

  • Investment Objectives means the investment objectives of the Fund as set forth in the Declaration of Trust as described in section 1.1.1 of this Annual Information Form.

  • Performance Target means the level of performance expected of the HSP in respect of a Performance Indicator or a Service Volume. “person or entity” includes any individual and any corporation, partnership, firm, joint venture or other single or collective form of organization under which business may be conducted.

  • Performance Measure means one or more of the following selected by the Committee to measure Company, Affiliate, and/or business unit performance for a Performance Period, whether in absolute or relative terms (including, without limitation, terms relative to a peer group or index): basic, diluted, or adjusted earnings per share; sales or revenue; earnings before interest, taxes, and other adjustments (in total or on a per share basis); basic or adjusted net income; returns on equity, assets, capital, revenue or similar measure; economic value added; working capital; total shareholder return; and product development, product market share, research, licensing, litigation, human resources, information services, mergers, acquisitions, sales of assets of Affiliates or business units. Each such measure shall be, to the extent applicable, determined in accordance with generally accepted accounting principles as consistently applied by the Company (or such other standard applied by the Committee) and, if so determined by the Committee, and in the case of a Performance Compensation Award, to the extent permitted under Code Section 162(m), adjusted to omit the effects of extraordinary items, gain or loss on the disposal of a business segment, unusual or infrequently occurring events and transactions and cumulative effects of changes in accounting principles. Performance Measures may vary from Performance Period to Performance Period and from Participant to Participant, and may be established on a stand-alone basis, in tandem or in the alternative.