MS/AL Radiation Oncology Research Partnership

. 26-42 其他传记小品(每份不超过四页-见说明书). 43-46 资源......................................................................................................................... 研究计划 47-68 修订申请简介(不超过3页).........................................................................................................NTA_ 补充申请简介(不超过一页)..............................................................................................不适用 不适用 A.特定目标........................................................................._。.................................................................................... _47 B.背景和意义..................................................._....................................................................................我‘“ 不适用__ C.初步研究/进度报告/(A-D项：不超过25页*)._ 第一阶段进度报告(仅限SBIP-JSTTR第二阶段)_*SBIRJSTTRh阶段项目A-D限制为15页。 D、研究设计和方法....................._|.....................................................................................不适用_ E.人类受试者......................................................................................................................-65 保护人体主体(如正面第4项为“是”则为必填项)__ 包括妇女(如果页面上的第4项标记为“是”，则为必填项)................................................................._65_。 包括Minodty(如果页面上的第4项标记为“是”，则需要)...............................................................65 包括儿童(如果主页上的第4项标记为“是”，则为必填项).................................................................65 数据和安全监测计划(如果页面上的第4项标记为‘_ES’，且临床阶段为1、II或III，则为必填项 建议进行试验.......................................................................................................................不适用 F.脊椎动物.....................................................................................................................__N/A_ G，文献引用........................................................................................................................……69 H.联合体/合同安排...................................................................................................................70 I.支持函(例如，咨询公司).................................................................................................................................J1-EA__ J.产品开发计划(SBIP-JSTTRII阶段和快速通道)..........................................................................不适用 核对表.........................................................................................................................75 检查是否 附录(五套整理。附录不需要页码。) 附录为 包括在内 除非特别要求，否则不得为/SB/R/S TTR阶段烫发/删除附件， 接受出版的出版物和稿件数量(不超过10份) 其他项目(列表)： 小灵通398(05101版)第3页表格第3页

........... 26-42 Other Biographical Sketches (Not to exceed four pages for each - See instructions)) ........................ 43-46 Resources ................................................................................................................................................. Research Plan 47-68 Introduction to Revised Application (Not to exceed 3 pages) ......................................................................................................... NtA_ Introduction to Supplemental Application (Not to exceed one page) .............................................................................................. N/A N/A A. Specific Aims ......................................................................... _. .................................................................................... _ 47 B. Background and Significance ................................................... _.................................................................................... I'" N/A__ C. Preliminary Studies/Progress Report/ _. (Items A-D: not to exceed 25 pages*) .._ Phase 1Progress Report (SBIP-JSTTR Phase II ONLY) _ * SBIRJSTTR Phase h Items A-D fimited to 15 pages. D, Research Design and Methods ............................................. _ | ..................................................................................... I N/A_ E. Human Subjects ................................................................................................................................................................. 64-65 Protection of Human Subjects (Required if Item 4 on the Face Page is marked "yes") __ 64 Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ................................................................. ___ 65_. Inclusion of Minodties (Required if Item 4 on the Face Page is marked "Yes") ............................................................... 65 Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ................................................................. 65 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked '_es" anda Phase 1, II, or III clinical trial is proposed ...................................................................................................................................................... N/A F. Vertebrate Animals ............................................................................................................................................................. __ N/A_ G, Literature Cited ................................................................................................................................................................... ..... 69 H. Consortium/Contractual Arrangements ............................................................................................................................... 70 I. Letters of Support (e,g., Consultants) ................................................................................................................................. j1 -EA__ J. Product Development Plan (SBIP-JSTTR Phase II and Fast-Track ONLY) .......................................................................... N/A Checklist .................................................................................................................................................... 75 Check if Appendix (Five collated sets. No page numbering necessary for Appendix.) Appendix is Included Appendices NOT PERM/TTED for Phase / SB/R/S TTR unless specifically solicited, Number of publications and manuscripts accepted for publication (not to exceed 10) Other items (list): PHS 398 (Rev. 05101) Page 3 Form Page 3