Clinical Trial Agreements definition

Clinical Trial Agreements has the meaning set forth in Section 5.7(b).
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Clinical Trial Agreements means the Columbus Trial Agreement, the Standalone Clinical Trial Agreement, the Three-Way Clinical Trial Agreement and the Other Clinical Trial Agreement.
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Clinical Trial Agreements shall have the meaning set forth in Section 4.1.
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Examples of Clinical Trial Agreements in a sentence

  • If required, a Clinical Trial Insurance statement/certificate will be provided to the IRB.The study is conducted in multiple countries; therefore, reimbursement and indemnification will be addressed on a country specific basis in the study documents and center Clinical Trial Agreements.

  • Furthermore, in the event that the PPP Allowance Agreement is terminated, the Consortium Agreement may be terminated by the Participants upon mutual written agreement and the prior written approval of Stichting LSH-TKI, provided that such termination is allowed in accordance with article 3.1 of the Revised CCMO Directive on the Assessment of Clinical Trial Agreements of 30 August 2011.

  • These are just some of the areas in which new laws and regulations- have recently been added to the extensive list of items that research administrators must review in Clinical Trial Agreements.

  • The agreements include, but are not limited to, Material Transfer Agreements (MTAs), Simple Letter Agreements (SLAs), IC Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CT As), Letters of Collection (LOCs), and Memoranda of Understanding (MOU).

  • SS will recruit into NIH StrokeNet trials under its own Clinical Trial Agreements.

  • Include subtasks associated with the establishments of Cooperative Research and Development Agreements (CRADAs), Memoranda of Understanding (MOU), Memoranda of Agreement (MOA), Data Sharing Agreements (DSAs), Material Transfer Agreements (MTAs) or Clinical Trial Agreements (CTAs).

  • This article from the ASCO Exemplary Attributes series shares expert advice and negotiation tips to assist sites with contract negotiations.• Proposed Standardized/Harmonized Clauses for Clinical Trial Agreements.

  • If required, a Clinical Trial Insurance statement/certificate will be provided to the IRB.The study is conducted in multiple countries, therefore reimbursement and indemnification will be addressed on a country specific basis in the study documents and center Clinical Trial Agreements.

  • This Consortium Agreement shall be automatically terminated upon rejection of the Project Application by Stichting LSH-TKI and may be terminated by the Parties upon mutual written agreement in the event that the PPP Allowance Agreement has been terminated, provided that such termination is allowed in accordance with article 3.1. of the Revised CCMO Directive on the Assessment of Clinical Trial Agreements of 30 August 2011.

  • If an award was received from a sponsor without a proposal having been submitted (i.e. Clinical Trial Agreements, Intergovernmental Personnel Agreements), this Step C can be skipped.


More Definitions of Clinical Trial Agreements

Clinical Trial Agreements means the agreements entered into by DOV, DOV Bermuda and/or Nascime in connection with the Clinical Trials.
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Clinical Trial Agreements means any Contract between the Seller or the Company, as applicable, with any research institution and, where applicable, any investigator, whereby the Seller or the Company, as applicable, sponsors a clinical research conducted by such research institution or investigator.
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Clinical Trial Agreements means those agreements identified as “Clinical Trial Agreements” in Exhibit A hereto;
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Clinical Trial Agreements means those certain agreements between Aventis and a Third Party listed on Exhibit 1.11.
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Related to Clinical Trial Agreements

  • 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.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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 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 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.

  • 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.

  • 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 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 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.

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

  • 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 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 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.

  • 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.

  • 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 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).

  • 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).

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Collaborative pharmacy practice agreement means a written and signed

  • 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 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 Plans has the meaning set forth in Section 3.2.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.