Secondary Research definition

Secondary Research means research that exceeds or differs from the research specified in the Protocol, including genetic research.
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Secondary Research means research conducted by investigators, not limited to NCI Investigators, using non-publicly available CRADA Data, de-identified Raw Data and/or Biospecimens collected from Human Subjects enrolled in the Protocol(s) under the CRADA. For clarity, Secondary Research is not Protocol Related Research as defined above, and occurs (i) for randomized phase 2 and phase 3 trials, after the DSMB data release and first presentation of the study results; and (ii) for early phase trials and non-randomized trials, after the completion of accrual and treatment of Human Subjects and first presentation of study results. For both (i) and (ii) under this paragraph, if no other presentation of study results has occurred, submission of a study results report to xxxxxxxxxxxxxx.xxx will constitute a presentation.
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Secondary Research shall have the meaning set forth in Section 3.3.9.
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Examples of Secondary Research in a sentence

  • On the other hand, Secondary Research utilised the MSME census data, information available with respective DICs and SLBCs, district level Credit plan, related research reports data from industry associations, reports of previous interventions carried out by other agencies earlier, District Industrial profiles prepared by the MSME-DI/DIC, etc.

  • Secondary Research, or the review of existing data and studies;3.

  • Below are two tables reflecting community views and findings: Jasper County, IATown Hall CHNA Findings: Areas of Strengths Key CHNA Wave #4 Secondary Research Conclusions found: IOWA HEALTH RANKINGS: According to the 2021 Robert Woods Health Rankings, Jasper County, IA was ranked 69th in Health Outcomes, 45th in Health Factors, and 70th in Physical Environmental Quality out of the 99 Counties.

  • The categories are:• Arts and Humanities• Social and Behavioral Sciences, Public Policy• International and Area Studies• Biological, Life and Health Sciences• Environmental and Earth Sciences• Physical and Computational Sciences Secondary Research Field: If applicable, please select a secondary research field from the list below that most closely describes your field of research.

  • The Secondary Data User undertakes to return to SAGE the results of the Secondary Research Project analysis (i.e. derived data or new data) for potential future sharing.

  • Data must be used only for the Secondary Research Project as detailed in Exhibit A and for no other use or purpose.

  • The Secondary Data User agrees that substantive changes made to the Secondary Research Project, and/or appointment by the Secondary Data User of another Principle Investigator to complete the Secondary Research Project, require execution of a new Agreement in which the new Principle Investigator and/or new Secondary Research Project are designated.

  • By reading the Literature Review and the Secondary Research, it can be clearly seen that the following conclusions to the research questions detailed above have been reached.

  • Site agrees and acknowledges that Sponsor may use the Biological Materials to conduct Secondary Research, subject to the informed consent and in accordance with applicable laws and regulations.

  • The Secondary Data User agrees to report promptly to SAGE any proposed change in the Secondary Research Project and any unanticipated problems involving risks to study participants or others.


More Definitions of Secondary Research

Secondary Research research that exceeds or differs from the research specified in the Protocol, including genetic research. Vedlejší výzkum: výzkum, který je nad rámec výzkumu popsaného v Protokolu nebo se od něj liší, například genetický výzkum. Intellectual Property: means any and all rights in and to ideas, formulae, inventions, discoveries, know-how, data, databases, documentation, reports, materials, writings, designs, computer software, processes, principles, methods, techniques and other information, including patents, trademarks, service marks, trade names, registered designs, design rights, copyrights and any rights or property similar to any of the foregoing in any part of the world, whether registered or not, together with the right to apply for the registration of any such rights. Duševní vlastnictví: veškerá práva k nápadům, lékovým formám, vynálezům, objevům, know-how, datům, databázím, dokumentaci, zprávám, materiálům, písemným záznamům, návrhům, počítačovému softwaru, procesům, principům, metodám a technikám a další informace, např. patenty, ochranné známky, ochranné známky služeb, obchodní názvy, zapsané vzory, autorská práva a další práva nebo vlastnictví podobné výše uvedeným položkám, a to kdekoli na světě bez ohledu na to, zda jsou zapsané, či nikoli, společně s právem žádat o jejich zapsání. RECITALS: Úvodní část:
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Related to Secondary Research

  • Basic research means any original investigation for the advancement of scientific or technological knowledge that will enhance the research capacity of this state in a way that increases the ability to attract to or develop companies, jobs, researchers, or students in this state.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

  • 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.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.

  • 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 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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 the JDC and that otherwise fit the foregoing definition.

  • 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.

  • 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 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.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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.

  • 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 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.

  • Sponsored research means research, training, and other sponsored activities as defined by the federal Executive Office of the President, Office of Management and Budget:

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Collaboration has the meaning set forth in Section 2.1.

  • 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 Trial means any human clinical trial of a Product.

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.