Secondary Research definition

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.
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Secondary Research shall have the meaning set forth in Section 3.3.9.
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Secondary Research means research that exceeds or differs from the research specified in the Protocol, including genetic research. 4.2 Each Party shall be responsible for its own processing of Personal Data and Medpace shall ensure that any Personal Data relating to a subject, Principal Investigator and/or Study Personnel, is collected, stored, used, disclosed and transferred in accordance with all applicable supranational and national privacy laws and with the informed consents that are or will be obtained from subjects. Principal Investigator shall be responsible for obtaining and providing Medpace with written consent (in the form agreed with Medpace) from each Study Personnel for the collection, use and disclosure of their Personal Data. 4.3 Medpace shall ensure that any collection, handling, transportation and retention of Biological Materials, is carried out in accordance with the Protocol, informed consent and all applicable laws and requirements. Institution 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 requirements. 4.
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Examples of Secondary Research in a sentence

  • Storage or Maintenance for Secondary Research for which Broad Consent is required.

  • NPRM Proposal To Exempt Secondary Research Use of Identifiable Private Information Where Notice Was GivenOne exemption proposed in the NPRM is not included in the final rule.

  • Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens (or Storage or Maintenance for Such Secondary Research Use) for Which Broad Consent Is Required (§ll.104(d)(7) and (8)) The final rule includes two exemptions related to the secondary research use (including storage or maintenance for such use) of identifiable private information and identifiable biospecimens that require a subject’s broad consent.

  • Project Information Member Campus• Title• Funding Type• Duration• Primary Focus Area• Secondary Focus Area• Primary Research Category• Secondary Research Category• Abstract/Impact Statement:Provide a brief summary (350 words or fewer, written for a generalist to understand) that describes the research and its benefit to society and/or the industry, that can also be used for promotional purposes.

  • Public Comments on the Proposed Exemptions for Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens (or Storage or Maintenance for Such Secondary Research Use) for Which Broad Consent Is RequiredIn combination, approximately 150 comments discussed these proposals.

  • Secondary Research to Benchmark LILU Kit Subprogram ContentsTetra Tech conducted a secondary benchmarking review on kit programs to determine how the FirstEnergy’s LILU program’s measures compare to other similar low income programs administered across the country to inform future program design The sampling strategy for the PY6 process evaluation effort is provided in Table 5-8 below.

  • Lot 1: Secondary Research; This lot will cover all secondary research requirements where understanding the existing evidence base is the principal focus of the work.

  • Exemption for the Storage and Maintenance of Biospecimens and IdentPrivate Information for Future, Unspecified Secondary Research Activities After Consent Has Been Sought and Obtained (NPRM at§§ ll.104(f)(1) and ll.111(a)(9))The NPRM proposes a specific exemption for storage and maintenance of biospecimens (regardless of identifiability) and identifiable private information for future, unspecified secondary research activities after consent has been sought and obtained.

  • While the details may vary form course to course, they will likely include, but not be limited to: (1) Secondary Research, (2) Applied Fieldwork, (3) Project-based deliverables, (4) Case Identification & Evaluation, (5) Current Event Assessment, (6) Personal Interviews, (7) Independent Readings, (8) Discipline / Experience Diaries, and (9) Reflection Papers.

  • SEGMENT E: PROGRESS ON THE IMPLEMENTATION OF SPECIFIC OBLIGATIONS AA.


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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Secondary Research means research that exceeds or differs from the research specified in the Protocol, including genetic research. 4.2 Each Party shall be responsible for its own processing of Personal Data and Medpace shall ensure that any Personal Data relating to a subject, Principal Investigator and/or Study Personnel, is collected, stored, used, disclosed and transferred in accordance with all applicable supranational and national privacy laws and with the informed consents that are or will be obtained from subjects. Principal Investigator shall be responsible for obtaining and providing Medpace with written consent (in the form agreed with Medpace) from each Study Personnel for the collection, use and disclosure of their Personal Data. 4.3 Medpace shall ensure that any collection, handling, transportation and retention of Biological Materials, is carried out in accordance with the Protocol, informed consent and all applicable laws and requirements. Institution and Principal Investigator agree and acknowledge that Sponsor may use the Biological Materials to conduct Secondary Research, 3.6 Smluvní strany se zavazují, že budou postupovat v souladu se všemi platnými a účinnými právními předpisy týkající se ochrany dat a soukromí (souhrnně „zákony o ochraně dat), především, nikoliv však výlučně Nařízením Evropského parlamentu a rady EU č. 2016/679 (Obecné nařízení o ochraně osobních údajů “GDPR”). 4.
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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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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.

  • Secondary school means a nonprofit institutional day or residential school including a public secondary charter school that provides secondary education for grades 9-12.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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 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 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 BMS 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

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