Scope of Study definition

Scope of Study. The proposed area for the location of the rowing facility is Rotary Park and vacant City property adjacent to Rotary Park extending north to the Trade Center. The study may encompass property outside this area as necessary to accommodate the required elements to facilitate rowing activities and competitions.
Scope of Study. This section should set out the scope of the learning requirements for the placement. • [In many cases it is likely that an established relationship will already exist between the Organisational Unit and the Work Placement Provider. In such cases, it is likely that the learning requirements are already well known]. • [If a new Work Placement Provider is involved, it is recommended that the Organisational Unit contact should discuss with the organisation’s placement contact what is expected from the placement and whether a written program of study should be developed. Issues to be covered could include: o what types of information and knowledge staff members share with students; o what, if any, form of report will be required on completion of the placement; and/or o any confidentiality requirements from the students]. The Organisational Unit will provide academic and other support to the student over the course of the work placement. The Organisational Unit contact will be available to provide advice to the student or the Work Placement Provider over the course of the placement. [An initial discussion between the Organisational Unit contact and Work Placement Provider contact is often advisable prior to the commencement of the placement].
Scope of Study means the projects and tasks, and associated Research Costs, specified in an approved Annual Research Plan and Budget for performance by Investigators at an individual Member Institution. “University’s Scope of Study” means the Scope of Study the responsibility for the performance of which the Consortium Committee allocates Investigators at University, subject to University’s review and approval as set forth in Section 3.2(ii).

Examples of Scope of Study in a sentence

  • The Scope of Study includes 31.12 km of Length starting from Km 8.00 of MDR to the end point of MDR.

  • I-3Product Definitions and Scope of Study..................................

  • Purpose and Scope of Study When a child is placed into the protective custody of the State of Maine’s Department of Health and Human Services Office of Child and Family Services (OCFS), a primary care physician performs a physicalexam within 72 hours to assess the child’s immediate health needs.

  • The number of deaths at the county level number is mainly collected from the population statistical books published by the provincial Statistics Bureaus in the 1980s.11 Scope of Study.

  • To identify strategies to minimize variation order.4 1.4 Scope of Study The scope of the study is focused on MARA Projects.

  • Initial situation In August 2023, the share of fully battery-electric vehicles in Germany was 14% of 2023 registrations.

  • We will choose to differentiate the x2 terms and to integrate the exponential.

  • The Scope of Study includes 31.1 km of Length starting from Km8.455 of MDR to the end point of MDR.

  • To find the relevancy in applying local material and earthwork balance in Kuala Lumpur 1.4 Scope of Study The evaluation of green index assessment for materials and resources consists of criteria such as recycled and reused materials, sustainable resources, waste management, and green products.

  • Neuros high-speed Turbo blowers – a relatively recent technology (to the U.S.) supplied by Houston Service Industry, Texas 1.4 Scope of Study Research problem Justification Globally, commercial energy consumption for treated safe drinking water accounts for 26 Quads (Quadrillion British Thermal Units) which bills for 7% of the total world consumption of electricity [1].


More Definitions of Scope of Study

Scope of Study means the research project to be performed by the Partners entitled, [“INSERT PROJECT TITLE”], which is attached hereto as Appendix l and incorporated herein by reference.
Scope of Study is a proposal that describes the research to be performed by the Partner(s), the identities and/or descriptions of the personnel working on Scope of Study, and the financial support requested of the UC Irvine Vision Research Consortium for the performance of its studies.

Related to Scope of Study

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is:

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Board of Studies means the Board of Studies of the University;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.