Clinical Trial Agreements definition

Clinical Trial Agreements shall have the meaning set forth in Section 4.1.
Sample 1Sample 2
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.
Sample 1Sample 2
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.
Sample 1

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.

  • 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).

  • 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.

  • 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.

  • Laws, Regulations, and Clinical Trial Agreements, Address at the Society of Research Administrators International 2004 Symposium.

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

  • 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.

  • 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).


More Definitions of Clinical Trial Agreements

Clinical Trial Agreements has the meaning set forth in Section 5.7(b).
Sample 1
Clinical Trial Agreements means the agreements entered into by DOV, DOV Bermuda and/or Nascime in connection with the Clinical Trials.
Sample 1
Clinical Trial Agreements means those agreements identified as “Clinical Trial Agreements” in Exhibit A hereto;
Sample 1
Clinical Trial Agreements means those certain agreements between Aventis and a Third Party listed on Exhibit 1.11.
Sample 1

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 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 clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

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

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such 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 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 human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.