Clinical Trial Authorisation definition

Clinical Trial Authorisation means a clinical trial authorised in accordance with Part 3 of the Medicines for Human Use (Clinical Trials) Regulations 2004.
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Clinical Trial Authorisation means a Clinical Trial authorised in accordance with the article 2 and 13i of the Dutch Medical Research Involving Human Subjects Act;
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Clinical Trial Authorisation means authorisation of the conduct of a clinical trial—
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Examples of Clinical Trial Authorisation in a sentence

  • The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions.

  • The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol.

  • The Parties shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Competent Authority and the opinion of the Ethics Committee; and the applicable Law.

  • The Sponsor may require, by written notice the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions.

  • The Parties shall conduct the Clinical Trial in accordance with the terms of this Agreement (including the incorporated Protocol) and: any current marketing authorisation in force within the relevant part of the UK for the IMP and, as the case may be, the Clinical Trial Authorisation granted by the MHRA; and the terms and conditions of the favourable opinion of the research ethics committee.

  • The Parties shall conduct the Clinical Trial in accordance with the terms of this Agreement (including the incorporated Protocol) and: any current marketing authorisation for the IMP and, as the case may be, the Clinical Trial Authorisation granted by the MHRA; and the terms and conditions of the favourable opinion of the research ethics committee.

  • Sponsor may require Institution and Principal Investigator to apply for the Clinical Trial Authorisation, in which case the Principal Investigator shall keep Sponsor fully apprised of the progress of the Ethics Committee submissions and shall upon request provide Sponsor with all correspondence relating to such submissions.

  • All Clinical Studies carried out by CMS which require a Clinical Trial Authorisation shall be undertaken in accordance with GCP and all Applicable Laws.

  • Obtain Clinical Trial Authorisation from Medicines and Healthcare Products Regulatory Agency Protocol Amendments Prepare and submit proposed substantial amendments of the Protocol to the regulatory authority(ies), relevant ethics committee and NHS Site.

  • This certificate will be issued further to a full qualitative and quantitative analysis of all active and other relevant constituents to ensure that the quality of the products complies with the requirements of the Marketing Authorisation (authorised products) / Clinical Trial Authorisation (investigational medicinal products) of the importing country.


More Definitions of Clinical Trial Authorisation

Clinical Trial Authorisation means a clinical trial authorised in accordance with the Czech legal requirement for approval by an Ethics Committee (of Act no. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended (hereinafter referred to as „Act on Pharmaceuticals“ ));
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Related to Clinical Trial Authorisation

  • Safety Authorisation and “deemed Safety Authorisation” have the meanings given to “safety authorisation” and “deemed safety authorisation” by the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • 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 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 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 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.

  • 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.

  • 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.

  • Authorisations means authorisations, orders, grants, recognitions, determinations, certificates, confirmations, consents, licences, clearances, provisions and approvals, in each case, of a Third Party.

  • Authorisation means an authorisation, consent, approval, resolution, licence, exemption, filing, notarisation or registration.

  • 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 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.

  • 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.

  • 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 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.

  • 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.