CLINICAL WORK definition

CLINICAL WORK means any work related to human trials to assess the dosing, safety and/or efficacy of a Product and/or to assess a dose and treatment plan employing such Product, including, but not limited to, Phase III and Phase IV Clinical Trials (in the event such Phase IV Clinical Trials are required by the FDA).
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CLINICAL WORK means any work related to human trials to assess the ------------- dosing, safety and/or efficacy of Licensed Products and/or to assess a dose and treatment plan employing such Licensed Products, including, but not limited to, Phase III and Phase IV Clinical Trials (in the event such Phase IV Clinical Trials are required by the FDA).
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Examples of CLINICAL WORK in a sentence

  • The following are examples of circumstances or performances that may form the basis for a remediation plan or for dismissal: COMPETENCY IN CLINICAL WORK, RESEARCH, AND TEACHING 1.

  • PHYSICAL THERAPY CLINICAL WORK EXPERIENCE1998-2002 Clinical Instructor, Federal School of Physiotherapy, Bayero University, Kano, Nigeria.

  • It is the responsibility of the site supervisor to monitor and provide direct or indirect supervision for ALL CLINICAL WORK conducted at the site.

  • It is the responsibility of the Site Supervisor to monitor and provide direct or indirect supervision for ALL CLINICAL WORK conducted at the agency/site.

  • IT IS IMPORTANT THAT EACH WRITTEN EVALUATION OF THE STUDENT’S CLINICAL WORK BE DISCUSSED IN PERSON WITH THE STUDENT, PRIOR TO BEING SIGNED AND FORWARDED TO THE CLINICAL COORDINATOR OF THE MFT PROGRAM.

  • RACIAL MICRO-AGGRESSIONS IN THE CLINICAL DYAD: A QUALITATIVE STUDY OF AFRICAN AMERICAN CLINICAL SOCIAL WORKERS:ANTI-OPPRESSION CLINICAL WORK WITH SAME RACE CLIENTS A project based upon an independent investigation, submitted in partial fulfillment of the requirements for the degree of Master of Social Work.

  • IT IS IMPORTANT THAT EVALUATIONS OF THE STUDENT’S CLINICAL WORK BE DISCUSSED IN PERSON WITH THE STUDENT PRIOR TO BEING SIGNED AND FORWARDED TO THE CLINICAL COORDINATOR OF THE MFT PROGRAM.

  • NHS CLINICAL WORK I was Director of the Medical Oncology service for NHS patients in the Oxfordshire region and for those adjacent regions with which we have contracts [till 2010].

  • NON AFFILIATING CLINICAL WORK EXPERIENCE (No Double Dipping)‌‌According to the JRCERT’s Standards for an Accredited Educational Program, the GRCC Program emphatically enforces the following policy, “The Program limits assigned student activities to educationally related and valid academic and clinical requirements”.

  • As shown in Table S-10: Summary of Impacted and Unmitigated Sidewalks (Platoon Conditions), significant adverse impacts would be fully mitigated at one sidewalk, while three sidewalks would remain unmitigated.

Related to CLINICAL WORK

  • 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.

  • Development Work means the work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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.

  • 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.

  • tidal work means so much of any work authorised by this Order as is on, under or over tidal waters or tidal lands below the level of high water;

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • 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).

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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.

  • Development Plan has the meaning set forth in Section 3.2.

  • Project Work means the work required to complete the Project.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Development Works means the external development works and internal development works on immovable property;

  • 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.

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

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • audiovisual work means a work that consists of a series of related images which impart the impression of motion, with or without accompanying sounds, susceptible of being made visible and, where accompanied by sounds, susceptible of being made audible;