Clinical Trial Agreements definition

Clinical Trial Agreements shall have the meaning set forth in Section 4.1.
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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 has the meaning set forth in Section 5.7(b).
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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.

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

  • 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.

  • 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).

  • 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.

  • 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.

  • For each incident, such approval will not be granted without the approval of the IP manufacturer and consideration of terms of existing DAIT Clinical Trial Agreements (CTAs) governing use of the IP in the specific trial.

  • Lisa Benson, BS, CCRP, Vice President, Clinical Research Operations, Quality & Education, Institute of Advanced Clinical Trials for ChildrenMs. Benson will discuss the contract review process and the importance of successful interactions between Sponsors, CROs and Sites when negotiating Clinical Trial Agreements.


More Definitions of Clinical Trial Agreements

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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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 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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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 any human clinical trial of a Product.

  • 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 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 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 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 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.

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

  • 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.

  • 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 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 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 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.

  • 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, 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.

  • 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 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.

  • 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.