Final Study Report. Corvus shall complete the Study as outlined in the Protocol. Corvus shall summarize the findings of the Study in a Final Study Report. Corvus shall provide the Final Study Report to Genentech within [***] after Database Lock. “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. As soon as possible, but in all cases within [***] ([***]) months after Data Lock for the applicable Clinical Trial, Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the final study report for the Phase 1 Clinical Trial for such Program (which shall be prepared in accordance with customary practice that meets the standards of ICH Topic E3 of ICH Guidelines for Structure and Content of Clinical Study Reports dated July 1996).
Final Study Report. Company shall provide Merck with an electronic draft of the final study report promptly following Study Completion, and Merck shall have [*****] days after receipt of such draft to provide comments thereon. Company shall consider in good faith any comments provided by Merck on the draft final study report and shall not include any statements relating to the Merck Compound that have not been approved by Merck. Company shall deliver to Merck a final version of the final study report promptly following finalization thereof (the “Final Study Report”). “Study Completion” shall occur upon database lock of the Study results.
Final Study Report. BioLineRx shall provide Merck with (i) an electronic draft of the final Study report, for Merck to provide comments to BioLineRx within [*] days of receipt of the draft of the final Study report and (ii) a final version of the final Study report (the “Final Study Report”) promptly following Study Completion. BioLineRx shall consider in good faith any comments provided by Merck on the draft of the final Study report and shall not include any statements relating to the Merck Compound [*]. “Study Completion” shall occur upon database lock of the Study results.
Final Study Report. Syndax shall use its best efforts to complete the Study as outlined in the Protocol. Syndax shall summarize the findings of the Study in a Final Study Report. Syndax shall provide the Final Study Report to Genentech within six (6) months after Database Lock. “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.
Final Study Report. Following the case studies, the contractor shall update and finalize the study report with key findings from secondary data analysis, survey analysis, and case studies, organized sby research question and with case studies also presented as vignettes within the report (Deliverable #15). The final report shall also highlight areas for further analysis and propose specific policy recommendations for the NEA and other stakeholders. The final report should align with the reporting/dissemination plan presented in the approved Research Plan. The report should include an executive summary with recommendations and should not exceed 60 pages at this stage. The contractor shall expect up to three rounds of feedback from the COR and other NEA staff on this report. At least one of these rounds of feedback will reflect input from the Technical Working Group. The contractor may opt for a work session with agency staff instead of one round of feedback. In addition to the final report, the contractor shall prepare the data and written material for 3-5 infographics that will be included in the report, but also can be used as stand- alone documents. Infographics will summarize key data and findings that pull qualitative and quantitative data from asset mapping, survey, and case studies (part of Deliverable #15). The contractor will not be responsible for the design of the infographics. Project Phase/Task Key Deliverables (see numbered deliverables in Detailed Specifications section)* Due Date (Weeks after Kick- off Mtg)
Final Study Report. 15. Final study report and infographics* 76 weeks *The contractor shall provide for up to three (3) rounds of feedback from the COR where indicated in the deliverable timeline above. Otherwise, the contactor shall expect one round of feedback on all other deliverables. The Offeror may propose alternative approaches to the Tasks listed above under 3. Detailed Specifications if there are other methods or activities that achieve the same project objectives more efficiently and/or with higher validity. Alternative methods could include short, tailored interviews with HBCU staff and leadership to collect data instead of a survey (Task #5d); a public town hall—held before a research plan is finalized—for HBCU staff and students to discuss current formal and informal arts and cultural assets and how they are being used in a variety of fields; and focus groups with 9 or fewer participants with tailored questions based on institution, regional location, and field expertise.
Final Study Report. The final study report will include all available efficacy, immunogenicity (including exploratory analyses) and safety data; clinical assessments; and concomitant medications from the duration of the study. Modifications or additions to the analyses described in Section 7.2 to Section 7.5 will be included in the SAP. Any decisions to deviate from the planned analyses described in the protocol and in the statistical analysis plan will be described in detail in the final study report.
Final Study Report. Antigen Express shall provide Merck with an electronic draft of the final study report promptly following Study Completion, and Merck shall have thirty (30) days after receipt of such draft to provide comments thereon. Antigen Express shall reasonably consider any comments provided by Merck on the draft final study report and shall not include any statements relating to the Merck Compound that have not been approved by Merck. Antigen Express shall deliver to Merck a final version of the final study report promptly following finalization thereof (the “Final Study Report”). “Study Completion” shall occur upon database lock of the Study results.
Final Study Report. FLX shall provide Merck with an electronic draft of the final Study report promptly following Study Completion, and Merck shall have [***] days after receipt of such draft to provide comments thereon. FLX shall consider in good faith any comments provided by Merck on the draft final Study report and shall not include any statements therein relating to the Merck Compound that have not been approved by Merck. FLX shall deliver to Merck a final version of the final Study report promptly following finalization thereof (the “Final Study Report”).
