Clinical Study definition

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.
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Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
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Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.
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Examples of Clinical Study in a sentence

  • Nothing in this clause 8 shall be construed so as to prevent or hinder the Site Parties from using the Know How generated during their conduct of the Clinical Study for their normal hospital, non-commercial research and education activities, to the extent such use does not result in the disclosure or misuse of Confidential Information or the infringement of any Intellectual Property Rights of the Sponsor.

  • The Study Site will ensure the availability of and/or access to any resources necessary to perform the Clinical Study at the Study Site, including departments, facilities and Research Staff and support personnel, and the Study Site certifies that the Site Investigator holds the necessary registration and has the necessary qualifications, expertise and time to perform the Clinical Study.

  • In consideration of the undertakings and commitments set forth herein, the Parties agree to enter into this Clinical Study Site Agreement.

  • All Intellectual Property Rights and Know How owned by or licensed to any of the Parties prior to and after the date of this Agreement, other than any Intellectual Property Rights and Know How arising from the Clinical Study, are and shall not be affected by this Agreement.

  • The Study Site shall notify the Sponsor if the Site Investigator ceases to be associated with the Study Site where the Clinical Study will be conducted or if he/she is otherwise unavailable to continue as Site Investigator, and Study Site shall use all reasonable endeavours to find a qualified successor acceptable to the Sponsor.


More Definitions of Clinical Study

Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.
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Clinical Study means any study in which human subjects are dosed or treated with a drug or biological product, whether approved or investigational.
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Clinical Study means any human clinical trial of a Product Candidate.
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Clinical Study means any investigation in relation to humans intended:
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Clinical Study means the investigation as defined in the cadre above, (also) to be conducted at the Study Site in accordance with the Protocol;
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Clinical Study means a Phase 1 Study, Phase 1/2 Study, Phase 2 Study, or Phase 3 Study, or such other study in humans that is conducted in accordance with cGCP and is designed to generate data in support or maintenance of an application for Regulatory Approval.
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Clinical Study means a clinical study in human subjects that has been approved by a Regulatory Authority and applicable institutional review board or ethics committee, and is designed to measure the safety and/or efficacy of a Licensed Product. Clinical Studies shall include, but not be limited to, Phase I Studies, Phase II Studies, Phase III Studies and any clinical studies required to be conducted by any Regulatory Authorities following receipt of Regulatory Approval.
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