Study plan deviation means an unintended departure from the study plan after the study initiation date.
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;
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:
Development Plan has the meaning set forth in Section 3.2.
Study means the investigation to be conducted in accordance with the Protocol.
Decommissioning Plan means the document containing detailed information on the proposed decommissioning and covering the following: the selected decommissioning strategy; the schedule, type and sequence of decommissioning activities; the waste management strategy applied, including clearance; the proposed end state; the storage and disposal of the waste from decommissioning; the timeframe for decommissioning; the cost estimates for the completion of decommissioning; and the objectives, expected results, milestones, target dates, as well as the corresponding key performance indicators, including, as appropriate, earned value based indicators. The plan is prepared by the nuclear facility license holder and is reflected in the multiannual work programmes of the Programme;
Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.
Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.
Architectural Review Committee or “ARC” shall mean the architectural review committee established by the Organization to review plans submitted to the Organization for architectural review.
Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;
Project Implementation Manual or “PIM” means the manual setting out the measures required for the implementation of the Project, as the same may be amended from time to time, subject to prior approval of the Association;
Utilization review plan or "plan" means a written procedure for performing review.
Improvement Plan means the plan required by the Authority from the Supplier which shall detail how the Supplier will improve the provision of the Goods and/or Services pursuant to Clause 29.1.1 (Authority Remedies);
Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.
Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.
Firm Transmission Feasibility Study means a study conducted by the Transmission Provider in accordance with Tariff, Part II, section 19.3 and Tariff, Part III, section 32.3.
Project Plan means the document to be developed by the Contractor and approved by WTL, based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalised Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by WTL. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.
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.
Quality Plan means the quality plan to be produced by the Contractor in accordance with Schedule S2-10 (Quality Plan);
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.
Project Implementation Unit or “PIU” means the unit referred to in Section I.A.1 of Schedule 2 to this Agreement.
The Project Plan means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.
Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Work Plan means a plan that describes each individual activity to be conducted to complete eligible activities and the associated costs of each individual activity.
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).
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.
Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.