Non-Interventional Studies definition

Non-Interventional Studies means studies in which results from the treatment of patients with pharmaceutical products are analysed with epidemiological methods. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Non-Interventional Studies means studies in which results from the treatment of patients with pharmaceutical products are analysed with
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Examples of Non-Interventional Studies in a sentence

  • Provisions and restrictions in the current text of the “Guidelines on Non-Interventional Studies Conducted with Drugs” (GNISCD), published by the Ministry, as well as the other applicable laws and regulations shall be complied with in addition to those specified in this article.

  • Non-Interventional Studies that are subject to National Contract Value Review must use an unmodified version of the Finance Schedule generated by the interactive Costing Tool (iCT).

  • With respect to HCO Fee for Service & Consultancy, Consultancy related engagements such as Consultantships, Fellowships, Retrospective Non-Interventional Studies, Healthcare Partnerships and Educational Services are included in the report.

  • According to the joint recommendations of the German competent authorities (BfArM and PEI) with regard to the Planning, Conduct, Analysis and Notification of Observational / Non-Interventional Studies the ethics committee responsible for the scientific leader of the study will be consulted.

  • Non-Interventional Studies are designed to answer specific questions about a new drug treatment when prescribed by an HCP to a patient.

  • Non-Interventional Studies – Any and all research that does not involve manipulating or changing the therapeutic interaction of a patient with a treatment or therapist shall be classified as non-interventional.

  • On the basis of data already available and not involving the patients concerned, this type of study is considered'retrospective' within the meaning of paragraph 1.4 of the Guide to the Evaluation of Non-Interventional Studies of May 2008 (2), and therefore does not fall within the scope of the Human Experiments Act (7 May 2004).

  • This also includes expenses for advisory boards, investigator meetings or the like, in case these are clearly connected to research and development activities.Additionally, according to the SFEE’s code on transparency in clinical trials, an electronic Registry of Non-Interventional Studies (“RNIS”) has been created and includes all registered non-interventional studies (with or without medicinal products) which are being conducted by SFEE member companies and admit study-subjects as of 1/1/2013.

  • The Observational Study will be performed in accordance with ethical principles that are consistent with the Declaration of Helsinki, ICH GCPs, GPP and the applicable legislation on Non-Interventional Studies and/or Observational Studies.

  • The site currently offers three protocol templates: (1) Interventional Studies; (2) Non-Interventional Studies; and (3) Retrospective Record Reviews.

Related to Non-Interventional Studies

  • Early intervention means, with respect to any Person, that any Relevant Spanish Resolution Authority or the European Central Bank shall have announced or determined that such Person has or shall become the subject of an “early intervention” (actuación temprana) as such term is defined in Law 11/2015 and in the SRM Regulation.

  • Early intervention services means individual programmes for children with developmental delays or disabilities, or children at risk of being developmentally delayed or of having a disability, aged 0 to 6 years, aimed at providing assistance to the child and its family in the areas of physical, emotional, social and educational needs.

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

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

  • Intervention means any action intended to reduce or avert exposure or the likelihood of exposure to sources which are not part of a controlled practice or which are out of control as a consequence of an accident;

  • 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).

  • Behavioral intervention means the implementation of strategies to address behavior that is dangerous, disruptive, or otherwise impedes the learning of a student or others.

  • Crisis intervention means the implementation of a service, support, or strategy to immediately stabilize a crisis and prevent the crisis from reoccurring after the crisis ends.

  • 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.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • 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.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • 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).

  • Behavior Intervention Plan (BIP) means a written plan that:

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • 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).

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

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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 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.

  • 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.