Schematic Representation of Study Design Clause Samples

The Schematic Representation of Study Design clause requires the inclusion of a visual or diagrammatic overview of the study's structure and methodology. This typically involves presenting a flowchart or timeline that outlines key phases, participant groups, interventions, and assessment points within the research. By providing a clear visual summary, the clause helps all parties quickly understand the study's organization, facilitating communication and reducing the risk of misunderstandings about the study's procedures.
Schematic Representation of Study Design. Approximately 1250 subjects will be randomized *** at up to *** study sites. The randomization schedule will be stratified by *** to ***; at least *** of subjects enrolled into the study will be ***. Subjects will initiate treatment with a dose titration during weeks 1-4 with doses gradually increased at *** intervals, as determined by randomization assignment, until the specified dose is reached and will be treated for 52 weeks (weeks 5-56) at the assigned dose level. Subjects will return to the site at the end of weeks 2 and 4 (Visits 3 and 4) during titration and at 4-week intervals thereafter. A schedule of events is provided in Appendix 1. The primary endpoints are differences between *** and *** groups in mean percent loss of baseline body weight, determined by weight at randomization (baseline) and weight at end of treatment (week 56), and percent of subjects with weight loss of 5% or more at end of treatment (week 56). Percent weight loss will be calculated as ***. Secondary efficacy endpoints are: · The difference in absolute weight loss between randomization (baseline) and end of treatment (week 56) for *** and *** groups. · The difference in percent of subjects who achieve a reduction in total body weight of at least 10% between randomization (baseline) and end of treatment (week 56) for *** and *** groups. · The difference in change in waist circumference (randomization to week 56) for *** and *** groups. Additional efficacy endpoints will include the effect of treatment on obesity-associated cardiovascular risk factors (total cholesterol, triglycerides, LDL-C, HDL-C, fasting glucose, blood pressure), ***, *** of *** and *** and ***, *** and ***. The difference between *** and *** groups in the rate of progression to type 2 diabetes will be calculated. Baseline adjusted Framingham 10-year risk scores will be calculated and compared between groups at weeks 28 and 56. Change in BMI between baseline and week 28 and end of treatment (Visit 17, week 56) will be evaluated. Additionally, body composition will be assessed by *** at ***. These evaluations will be made at ***, and at *** and ***. The change in weight loss (percent, absolute, percent of subjects achieving weight loss of > 5% and > 10% of starting weight), waist circumference and obesity associated risk factors will also be assessed over time. Subgroup analyses, including but not limited to analysis by gender, age and race, may be performed. Safety evaluations will include assessment of ad...
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Related to Schematic Representation of Study Design

  • Schematic Design See Section 2, Part 1, Article 2.1.4, Paragraph 2.1.4.2.

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • Separation of Components The SOFTWARE PRODUCT is licensed as a single product. Its component parts may not be separated for use on more than one computer.

  • Execution of Change Orders Change Orders shall be signed by the Contractor, ordinarily certified by the Design Professional, and approved by the Owner in accordance with the form of Change Order prescribed by the Owner. No request for payment by the Contractor for a Change Order shall be due, nor shall any such request appear on an Application for Payment, until the Change Order is executed by the Owner. In the event of emergency (see Article

  • Schematic Design Phase 1.2.1 Based on the mutually agreed upon Program of Requirements, Amount Available for the Construction Contract and the Project Schedule, the Architect/Engineer shall prepare sufficient alternative approaches utilizing BIM for design and construction of the Project to satisfy Owner’s project requirements and shall, at completion of this phase, submit Schematic Design Documents derived from the model in accordance with the BIM Execution Plan, “Facility Design Guidelines” and any additional requirements set forth in Article 15. The Architect/Engineer shall review alternative approaches to design and construction for the Project as they are being modeled at intervals appropriate to the progress of the Project with the Owner and Construction Manager at the Project site or other location specified by the Owner within the State of Texas. The Architect/Engineer shall utilize the model(s) to support the review process during Schematic Design. The Architect/Engineer shall provide the Construction Manager with a compact disc containing documents and data files derived from the model to assist the Construction Manager in fulfilling its responsibilities to the Owner. 1.2.2 Architect/Engineer shall provide all services necessary to perform the services of this phase (preparation of model(s), relevant data, decision support model views and Schematic Design Documents) including, without limitation, unless otherwise approved by Owner, the preparation and prompt delivery of all items specified in the BIM Execution Plan and “Facility Design Guidelines”. 1.2.3 Architect/Engineer shall work closely with Owner in preparation of schematic drawings and shall specifically conform to Owner’s requirements regarding aesthetic design issues. 1.2.4 The Architect/Engineer shall review the Estimated Construction Cost prepared by the Construction Manager, and shall provide written comments. 1.2.5 Before proceeding into the Design Development Phase, the Architect/Engineer shall obtain Owner’s written acceptance of the Schematic Design documents and approval of the Architect/Engineer’s preliminary Estimated Construction Cost and schedule. 1.2.6 The Architect/Engineer shall participate in a final review of the Schematic Design Documents and model(s) with the Owner and Construction Manager at the Project site or other location specified by Owner in the State of Texas. Prior to the Owner’s approval of the Schematic Design Documents, the Architect/Engineer shall incorporate such changes as are necessary to satisfy the Owner’s review comments, any of which may be appealed for good cause.