Final Study Report definition

Final Study Report has the meaning set forth in Section 3.11.
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Final Study Report means a formal clinical study report documenting and summarizing the results and interpretation of the Study, including the trial design, trial objectives, patient assessment, data analysis, results, risk/benefit analysis, safety and effectiveness, in accordance with the requirements of then-existing Regulatory Authority rules, regulations and guidance on the structure and content of clinical study reports.
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Final Study Report is defined in Section 2.8(c).
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Examples of Final Study Report in a sentence

  • The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until delivery of the Final Study Report, unless terminated earlier by either Party pursuant to this Article 6 (the “Term”).

  • The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until the earlier of (i) delivery of the Final Study Report and (ii) Study Completion plus three (3) months, or until terminated by either Party pursuant to this Article 6 (the “Term”).

  • Corvus shall provide the Final Study Report to Genentech within [***] after Database Lock.

  • For a period of [***] ([***]) calendar days from and after the delivery of such Final Study Report, Novartis shall have the right to request from Akcea such additional information then in the possession of or readily available to Akcea as Novartis may reasonably require regarding the Phase 2 Dose-Ranging Trial, and Akcea shall promptly provide or make available to Novartis any such additional information that Akcea has not previously delivered to Novartis.

  • Liard River Environmental Quality Monitoring Program: Final Study Report.


More Definitions of Final Study Report

Final Study Report is defined in Section 1.1(c).
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Final Study Report shall have the meaning ascribed to such term in Section 2.1.
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Final Study Report means a formal clinical study report documenting and summarizing the results and interpretation of the Study, including the trial design, trial objectives, patient assessment, data analysis, results, risk/benefit analysis, safety and effectiveness, in accordance with the requirements of Regulatory Authorities on the structure and content of clinical study reports.
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Final Study Report means the document prepared at the end of the Bridging Study that describes the objectives, design, methodology, statistical analysis, results and conclusions of such Bridging Study.
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Final Study Report means the document prepared at the end of the Study that describes the objectives, design, methodology, statistical analysis, results and conclusions of the Study including the CRFs.
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Final Study Report has the meaning as defined in Section 3.1.
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Final Study Report means the study report from the Study by the study investigators, including completed case report forms for all patients who participated in the Study, as such study report is in the form that would be filed with the FDA and is in conformity with the requirements of “Clinical Study Reports” as outlined in the guideline “ICH E3 Guidance, Structure and Content of Clinical Study Reports”. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
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