Study Phase definition

Study Phase means, for a clinical trial of a drug product (including a bio- logical product), the numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21, such as phase 2 or phase 3, and in 21 CFR 312.85 for phase 4 studies.
Sample 1Sample 2Sample 3
Study Phase is a Phase that may occur prior to project funding and typically includes program development, financial pro-formas and security risk assessment. RECORD DOCUMENTS: are the Construction Documents, amended to show the Project as it was constructed. Record Documents include any significant changes or clarifications to the Construction Documents resulting from the construction process. STOP SERVICES ORDER: is a written notice, delivered in accordance with this Agreement, by which the AOC may require the Architect to stop all, or any part, of the Services under this Agreement, for the period set forth in the Stop Services Order. The Stop Services Order shall be specifically identified as such and shall indicate that it is issued pursuant to the Stop Services provision in section C.13 of Exhibit C. SUSTAINABLE BUILDING MEASURES: are elements of the design that result in minimizing pollution, resource waste, and environmental impacts associated with facility construction operation and, if applicable, demolition.
Sample 1Sample 2
Study Phase. The portion of this Project that commences upon the receipt of a Notice to Proceed for an Approved Scope of Services that includes Study services and concludes upon the decision by Awarding Authority regarding Certification of Study. The Study Phase includes the Schematic Design Phase.
Sample 1Sample 2

Examples of Study Phase in a sentence

  • As part of the Regional Solicitation Before & After Study, Phase 2 (2021), a list of commonly used crash modification factors was created.

  • In addition, bidder must have completed a System-Impact Study, Cluster Study Phase 1, or have passed the Fast Track screens.

  • Source: Alcohol and Drug Services Study, Phase II Client Record Abstract data (weighted).

  • Designers awarded a contract for the Study Phase are not guaranteed to be awarded the Design Phase.

  • The Designer shall familiarize itself with the Authority’s Guidelines and Standards for feasibility studies that further specify the work to be performed by the Designer during this Phase and shall perform its Feasibility Study Phase services in accordance with such Guidelines and Standards and the provisions of this Contract.

  • Summary of the VAR requirements based upon the results of the dynamic studies) To be determined in the Facilities Study Phase.

  • Progress payments for Basic Services for each phase of work shall be made in proportion to services performed as follows:Phase AmountSchematic Design/Preliminary Study Phase $ Design Development Phase $ Bidding, Construction & Contract Document Phase $ Bidding & Award Phase $ Construction Phase $ Post Completion/ Warranty Phase $ Total Basic Services $ B.

  • The contract will be signed when the study services are procured, but there will be a break from the Study Phase to the Design Phase for study certification and finalizations of the Design and Construction Administration scope of services.

  • The Awarding Authority compensates the Designer during the Study Phase for approved products in accordance with the approved work plan.

  • The Town of Olive signed the contract and resolution to proceed with the Study Phase on August 14, 2018.


More Definitions of Study Phase

Study Phase. The phase of a Project occurring prior to the execution of a Design Contract, or a Design/Build Contract. This may include any portion of a project performed prior to the Design Phase when a study is not required pursuant to M.G.L. c. 7C.
Sample 1
Study Phase is the phase in which LESSOR conducted a feasibility study encompassing a preliminary technical-financial dimensioning of the PV System and demonstrating benefits in electricity savings at the Establishment. Its purpose is to show the expectation of generation, by the PV System during the Lease Term, of a global reduction in the electricity cost projected for the Establishment, as well as provide better management and predictability of such electricity costs.
Sample 1
Study Phase is the phase in which GY BRASIL carried out the feasibility study comprising a preliminary technical and financial dimensioning of the PV System, presenting the benefits of this for the electricity savings in the Establishment. It aims to demonstrate the expectation of the PV System and, during the Term of Effectiveness, generate a global reduction in the cost of electricity projected in the Establishment, as well as providing greater management and predictability of such electricity costs.
Sample 1
Study Phase. [Click here to enter text] Research Hypothesis: [Click here to enter text] Objectives: [Click here to enter text]
Sample 1
Study Phase means a period of three (3) years, calculated from the Closing Date (unless extended in terms of clause 10.3.3;
Sample 1

Related to Study Phase

  • Development Phase means the period before a vehicle type is type approved.

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Study Period means the period commencing at 9:00 a.m. on the date hereof, and continuing through 5:00 p.m. on the Closing Date.

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • 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).

  • Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • Phase or “Phases” in respect of the Project shall mean that the components of the Project are placed in service during more than one year during the Investment Period, and the word “Phase” shall therefore refer to the applicable portion of the Project placed in service in a given year during the Investment Period.

  • Feasibility Study means a comprehensive study of a deposit in which all geological, engineering, operating, economic and other relevant factors are considered in sufficient detail that it could reasonably serve as the basis for a final decision by a financial institution to finance the development of the deposit for mineral production;

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

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

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Construction Phase means that Phase of the Project which shall commence after the Authority provides the Trade Contractor with written Notice to Proceed with the Construction Phase.

  • 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 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • 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).

  • Design Phase means the period during which the Transporter shall prepare a draft project proposal for publication in accordance with section 4.3;

  • Construction Phase Services means the coordination, implementation and execution of the Work required by this Agreement, which are further defined in Article 8.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Development Program means the implementation of the development plan.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.