Final Study Report has the meaning set forth in Section 3.11.
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.
Final Study Report is defined in Section 2.8(c).
Examples of Final Study Report in a sentence
London, 21 July 2011, p.13-14; Novagenix's SOP-NOV-ENG-08-CQU4 and documented in the Final Study Report.
All drop-out samples which will be sent by the clinic will be analysed and results will be given in the Final Study Report.
First, the study aimed at identifying the key determinants of utility growth; with a special focus on revenue and tariff growth.
At that point a further decision by the Sponsor will be taken.20% of the chromatograms are to be included in printed Final Study Report.
Prior to issuing the Final Study Report, NOVAGENIX will prepare a draft report according to the ICH guideline for approval by sponsor.
More Definitions of Final Study Report
Final Study Report is defined in Section 1.1(c).
Final Study Report shall have the meaning ascribed to such term in Section 2.1.
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.
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.
Final Study Report shall have the meaning ascribed in Appendix I hereto.
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.
Final Study Report means the final report in respect of the Study written by or on behalf of Palatin and summarising the results of the Study as more particularly described in Schedule 1.12