General Clinical Research Center

全科临床研究中心

• 批准号: 7014609
• 负责人: ROBERT P KELCH
• 金额: $ 576.22万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-20 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7014609
• 关键词: clinical research; human subject

exceed character length restrictions'mdicated. -. IRG: 2RR1 SRC(99) Received: 02/0 1/2005 1. TITLE OF PROJECT (Do not exceed 56 characters, including spaces and pun^iuaiujn./ General Clinical Research Center 2. RESPONSE TO SPECIFIC REQUEST FORAPPLICATIONS OR PROGRAMANNOUNCEMENT OR SOLICITATION IE! NO D YES (If "Yes, "state number and title) Number: Title: 3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR New Investigator |^3 No l~1 Yes 3a. NAME (Last, first, middle) 3b. DEGREE(S) Kelch, Robert P. M.D. ¿ ', 3c. POSITION TITLE 3d. MAILING ADDRESS (Street, city, state, zip code) Principal Investigator General Clinical Research Center 3e. DEPARTMENT, SERVICE, LABORATORY,OR EQUIVALENT 1500 E. Medical Center Drive Internal Medicine Ann Arbor, Ml 48109-0108 3f. MAJOR SUBDIVISION Medical School 3g. TELEPHONE AND FAX (Area code, number and extension) E-MAILADDRESS: TEL: [phone] FAX: [phone] [e-mail] 4. HUMAN SUBJECTS 43.Research Exempt M No D Yes 5. VERTEBRATE ANIMALS IE! No D Yes RESEARCH |f .yes Exemption No / D N0 4b. Human Subjects 4c. NIH-defined PhaseIII 5a. If "Yes,' IACUC 5b. Animal welfare assuranceno. V| yes Assurance No. Clinical Trial approval Date FWA00004969 [X] No D Yes A3114-01 6. DATES OF PROPOSEDPERIOD OF 7. COSTS REQUESTEDFOR INITIAL 8. COSTS REQUESTED FORPROPOSED SUPPORT (month, day, yearMM/DD/YY) BUDGET PERIOD PERIOD OFSUPPORT rrom Through 7a. Direct Costs ($) 7b. Total Costs ($) 8a. Direct Costs ($) 8b. Total Costs ($) 3/1/2006 2/28/2011 $6,543,962 $7,112,996 $34,472,530 $37,479,141 9. APPLICANT ORGANIZATION 10. TYPE OF ORGANIZATION Name The Regents of the University of Michigan Public: -> D Federal ¿3 State D Local Address 3014 Fleming Private: -¿ I I Private Nonprofit Ann Arbor, Ml 48109-1340 For-profit: -> I I General I I Small Business H] Woman-owned I I Socially and Economically Disadvantaged 11. ENTITY IDENTIFICATION NUMBER 1386006309A1 DUNS NO. 073133571 Institutional Profile File Number (if known) Congressional District 15th 12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE 13. OFFICIAL SIGNING FOR APPLICANTORGANIZATION Name James Randolph Name James Randolph Title Senior Associate Director Title Senior Associate Director Address Division of Research Development and Administration Address pivision of Research Development and Admin. 3003 South State St., Room 1044 3003 South State Street, Room 1044 Ann Arbor, Ml 48109-1274 Ann Arbor, Ml 48109-1 274 Tel: [phone] FAX: [phone] Tel: [phone] FAX:[phone] E-Mail: [e-mail] E-Mail: [e-mail] 14. PRINCIPALINVESTIGATOR/PROGRAMDIRECTOR ASSURANCE: I certify that the SIGNATURE OF PI/PD NAMED IN 3a. DATE statements herein are true, complete and accurate to the best of my knowledge. I am (Inink. "Per" signature notaccaettfable.I i .-. aware that any false, fictitious, or fraudulent statements or claims may subject me to corinmdiuncatl,ocfivthil,eoprraodjemctinainsdtratotivperopveindaelttihees.reIqaugireed tporoagcrcespst repsoprotnssifibailigtyrafonrt itsheawscairednetdificas -7Z$%&^**- lH* a result of this application. 15. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that SIGNATURE OF OFFICIAL NAMKTIN 1 3. DATE taishceacewsptatrtdethmedeoanbstsligahareteirosenuinltoaorfceothmtrisupealy,pcwpolimtchapPtlieoutnbe.licaInHadmeacaltcwhuaSrraetertvhticoaettshaenteybrmefasltseao,nf dfmicytiotiknonduoistwi,olnoesrdfgirfeaa,uadgnuradlentt (I^nin^kier"^sig^na<ju^^jtat-=s/xje:m^ab_jis.) _^ '/,"/o^: statements or claims may subject me to criminal, civil, or administrative penalties. PHS 398 (Rev.05/01) Face Page Form Page 1 1

超出指定的字符长度限制。-。IRG：2RR1 SRC(99)收到：02/01/2005 1.项目名称(不超过56个字符，包括空格和双关语。/ 综合临床研究中心 2.对申请或规划或征集的具体请求作出回应，例如！不是，D是 (如“是”，请述明编号及标题) 编号：标题： 3.首席调查员/项目总监新调查员|^3否L~1是 3A.姓名(姓、名、中)3b.学位(S) 罗伯特·P.M.D.凯尔奇， 3C。职位头衔3D。邮寄地址(街道、城市、州、邮政编码) 总临床研究中心首席研究员 3E。科室、服务部门、实验室或同等级别的1500 E号医疗中心大道 内科 安娜堡，ML 48109-0108. 3F。主要分部 医学院 3G。电话和传真(区号、号码和分机)电子邮件： 电话：734-936-8080传真：734-936-4024 4.人类受试者43.研究豁免M否D是5.脊椎动物IE！不是D是的 研究|f.是豁免否/ 第04B号。人体受试者4c。NIH定义的阶段III 5a。如果“是，‘IACUC 5b.动物福利保证否。 V|是保证编号临床试验批准日期 FWA00004969[X]否D是A3114-01 6.提交日期7.最初申请的费用8.申请的费用 支持(月、日、年/月/日/年)预算期间支持期间 Rrom到7a。直接成本(70亿美元)。总成本(美元)8a。直接成本($)80亿。总成本(美元) 3/1/2006 2/28/2011$6,543,962$7,112,996$34,472,530$37,479,141 9.申请组织10.组织类型 说出密歇根大学公共分校的董事名单：-&&gt；D Federal？3 State D Local 地址：3014 Fleming Private：？i i Private非营利组织 安娜堡，ML 48109-1340盈利性组织：-&gt；I I General I I Small Business H.妇女拥有的i社会和经济上处于不利地位 11.实体识别号 1386006309A1 邓氏073133571号 机构档案编号(如果知道)国会第15区 12.如作出裁决，须通知行政官员13.申请批准的正式签署 姓名詹姆斯·伦道夫姓名詹姆斯·伦道夫 职称高级副主任职称高级副主任 研究、开发和行政部门，研究、开发和管理部门。 南州街3003号，1044室，3003号，1044室 安娜堡，邮编：48109-1274；邮编：48109-1274 电话：[phone]传真：[phone] 电子邮件：[e-mail] 14.首席调查员/公署主任保证：本人证明3a所指名的公署/公署的签署。日期 据我所知，此处的陈述真实、完整、准确。我是(Inink.)“每个”签名不符合事实。i.i. 意识到任何虚假、虚构或欺诈性的陈述或声明可能会使我 Cinmdiuncatl，ocfivthil，eoprraodjemctinainsdtratotivperopveindaelttihees.reIqaugireed tporoagcrcespst epsoprotnssifibailigtyrafonrt it Sheawscrednetdifias-7Z$%&^**-lh* 这个应用程序的结果。 15.申请组织证明和验收：本人证明正式姓名签署日期 Taishceacewsptatrtdethmedeoanbstsligahareteirosenuinltoaorfceothmtrisupealy，pcwpolimtchapPtlieoutnbe.licaInHadmeacaltcwhuaSrraetertvhticoaettshaenteybrmefasltseao，nf dfmicytiitiknon duoistwi，olnoesrdfGirfea，uadgnuradlentt(I^nin^kier“^sig^na&lt；ju^^jtat-=s/xje:m^ab_jis.)_^‘/，”/o^： 声明或索赔可能会使我受到刑事、民事或行政处罚。 小灵通398(05/01版)正面页表格第1页 1