Clinical Trial Agreements definition

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 has the meaning set forth in Section 5.7(b).
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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

  • The Parties acknowledge that if the Project consists of the performance of clinical research that is subject to the Dutch Medical Research Involving Human Subjects Act (WMO), publication arrangements under Sections 8.9 and 8.10 are subject to the Revised CCMO Directive on the Assessment of Clinical Trial Agreements of 30 August 2011, and that in case of any conflict, the latter shall prevail.

  • 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.

  • Prior to the end of Phase II Clinical Trials of each Franchise Product in the Co-Promotion Territory and subject to the applicable publication provisions of any Clinical Trial Agreements with investigators, the JDC with appropriate input from the JCC will determine the overall strategy for publication in support of such Franchise Product in the Co-Promotion Territory.

  • Clinical Trial Agreements (CTAs) between the pharmaceutical industry and NIH Institutes for the clinical development of new methods of therapy are part of the NIH mission to improve treatment of specific diseases.

  • Michelle Mello, et al., “Academic Medical Centers’ Standards for Clinical- Trial Agreements with Industry,” The New England Journal of Medicine, vol.

  • This document sets out the procedures to be followed by all Royal Free London staff who are involved in the preparation and / or review of research study contracts or Clinical Trial Agreements (CTAs).

  • PNP represents that Exhibit P provides a full list of all Gedeptin® Clinical Trial Agreements that have ever been in effect, along with whether the Agreements are in still force or have been terminated.

  • 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 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.

  • 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.


More Definitions of Clinical Trial Agreements

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 certain agreements between Aventis and a Third Party listed on Exhibit 1.11.
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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 the agreements entered into by DOV, DOV Bermuda and/or Nascime in connection with the Clinical Trials.
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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 human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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 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 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • 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 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.

  • Development Agreements means all development, utility or similar agreements included in the Permitted Encumbrances.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

  • 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 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 II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.

  • 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 human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign 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 Product, a human clinical trial that is intended to initially evaluate the safety, metabolism and pharmacokinetics of such Product that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country other than the United States.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials 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 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 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 means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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.