9-Investigational Agent Management

Agent技术在集装箱码头管理系统中的应用的开题报告一、研究背景随着全球化和贸易自由化的进一步发展，国际贸易日益增长，集装箱作为一种重要的运输方式，运输量也在不断攀升。

集装箱作为一种安全、快捷、高效的运输方式，已经成为现代物流体系中不可或缺的一部分。

集装箱码头作为集装箱运输的重要组成部分，其作用越来越引人注目。

集装箱码头作为货物的枢纽，一直扮演着物流链条中不可替代的角色，对港口建设和装卸作业过程的出行安全管理具有重要意义。

同时，随着物流行业的迅速发展，集装箱码头的规模和容量不断扩大，进一步加剧了管理难度，大大增加了码头的安全风险。

因此，如何提高集装箱码头管理效率，保障集装箱码头安全生产，成为一个重要的研究方向。

二、研究目的本文旨在研究Agent技术在集装箱码头管理中的应用，通过构建基于Agent的集装箱码头管理系统，探索Agent技术在集装箱码头管理中的有效性。

三、研究内容1. 集装箱码头管理流程分析2. Agent技术概述3. 基于Agent的集装箱码头管理系统设计4. 集装箱码头管理系统实现与测试5. 结果分析与讨论四、研究意义1. 通过引入Agent技术，提高集装箱码头管理效率。

2. 提高集装箱码头管理的安全性和可靠性。

3. 探索一种新的集装箱码头管理方法和思路。

五、参考文献1. Agarwal, D.; Midha, P.; Jain, P.; Yadav, H.K. Multi-Agent System for Container Terminal Management. In Proceedings of the 2018 International Conference on Signal Processing and Communication (ICSC), Noida, India, 23–25 February 2018.2. Li, H.L.; Pei, L.; Xu, X.Z. Research on Multi-Agent System of Container Terminal Based on JADE. In Proceedings of the 2nd International Conference on Robot, Vision and Signal Processing (RVSP), Shanghai, China, 16–18 November 2018.3. Zhang, P.; Li, T. Modeling and Simulation of Container Terminal Operations Based on Multi-Agent System. In Proceedings of the 2019 IEEE International Conference on Computational Science and Engineering (CSE), Guangzhou, China, 18–21 August 2019.4. Wan, M.Y.; He, P.; Jiang, Y.P. Research on Container Terminal Intelligent Dispatching Model Based on Multi-Agent System. In Proceedings of the 2019 5th International Conference on Control, Automation and Robotics (ICCAR), Beijing, China, 22–24 April 2019.。

ELEMENTS NOT APPLICABLE TO A PARTICULAR SUBCONTRACTOR〔不适合特殊分供方的条款〕Certai.element.suc.a.4..(Contro.o.Custome.Supplie.Product.an.4.1.(Servicing.w il.no.appl.t.ever.supplier.I.suc.cases.‘N/A.i.entere.i.plac.o.th.score.REPORTING OF ASSESSMENT FINDINGS〔审核结果的报告〕The supplier assessment report shall be filed along with this assessment form for reporting and recommendation on supplier selection and approval.〔供给商评估报告应连同此评估表格作为报告、建议新供方的选择以及批准〕MINIMUM CRITERIA FOR ACCEPTANCE〔新供方承受的最小准那么〕1. The supplier (including Specially designated small supplier〔包括指定的特别小供方〕) should score minimum 40-60% & score minimum 5 points on the following elements individually for acceptance as approved supplier.〔至少得分在40-60%以及至少分别在下面条款中得到5分, 方可批准为供方〕2. Product identification and traceability.〔产品标识与可追溯性〕3. Control plan.(控制方案)4. Contract review.〔合同评审〕5. Control of customer supplied products.〔顾客财产保护〕6. Process monitoring operation instructions.〔过程监控作业指导书〕7. Control of non confirming products.〔不合格品控制〕8. Inspection status.〔检验状况〕9. Calibration status.〔校验状况〕10. Corrective action on customer complaints.〔客户抱怨纠正行动〕11. Compliance with customer's standards/requirements.〔遵守客户标准与要求〕12. Control of quality records〔质量记录控制〕-▪------------------ASSESSMENT DONE BY: Signature:Name:Date:。

ID WORDS WORD Family S_Frequency W_Frequency 1a indefinite article S1W12abandon v N/A W33ability n S2W14able adj S1W15about prep S1W16about adv S1W17above adv S2W18above adj N/A W39abroad adv S2W310absence n S3W211absolute adj S2W312absolutely adv S1W313absorb v N/A W314abuse n S2W315academic adj N/A W216accept v S1W117acceptable adj S3W318access n S2W119accident n S2W220accommodation n S2W221accompany v N/A W222according to prep S2W123account n S1W124account v S3W225accurate adj S2W326accuse v N/A W327achieve v S2W128achievement n S3W229acid n N/A W330acknowledge v S3W331acquire v N/A W232across adv S1W133act n S1W134act v S2W135action n S1W136active adj S2W237activist n S3N/A38activity n S2W139actor n N/A W340actual adj S1W241actually adv S1W142ad n S3W343adapt v N/A W344add v S1W145addition n S3W146additional adj S3W247address n S2W248address v S2W249adequate adj S3W350adjust v N/A W351administration n S2W252administrative adj N/A W353admire v S3N/A54admission n N/A W3 55admit v S2W1 56adopt v S3W2 57adult n S2W2 58adult adj N/A W3 59advance n S2W2 60advance v N/A W3 61advanced adj N/A W3 62advantage n S2W1 63advert n S3N/A 64advertise v S3W3 65advertisement n S3N/A 66advertising n N/A W3 67advice n S2W2 68advise v S2W2 69adviser n S3W3 70affair n S2W1 71affect v S2W1 72afford v S1W3 73afraid adj S1W2 74after prep S1W1 75afternoon n S1W2 76afterwards adv S2W3 77again adv S1W1 78against prep S1W1 79age n S1W1 80aged adj N/A W3 81agency n S3W1 82agent n S3W2 83aggressive adj S3N/A 84ago adv S1W1 85agree v S1W1 86agreement n S2W1 87agriculture n N/A W2 88ahead adv S1W2 89aid n S2W2 90aim n S2W2 91aim v S2W2 92air n S1W1 93aircraft n S2W2 94airline n S2W3 95airport n S3W3 96alarm n S2N/A 97album n S3W3 98alcohol n N/A W3 99alive adj S2W3 100all determiner S1W1 101all adv S1W1 102allow v S1W1 103allowance n S2W3 104all right adj S1W2 105almost adv S1W1 106alone adj S2W1 107along adv S1W1108along prep S1W1 109alongside adv N/A W3 110already adv S1W1 111also adv S1W1 112alter v S3W3 113alternative adj S2W2 114alternative n S2W3 115although conjunction S1W1 116altogether adv S2W3 117always adv S1W1 118amazing adj S2N/A 119ambition n N/A W3 120ambulance n S3N/A 121among prep S2W1 122amount n S1W1 123an indefinite article S1W1 124analyse v N/A W3 125analysis n S3W1 126analyst n N/A W2 127ancient adj N/A W2 128and conjunction S1W1 129anger n N/A W3 130angle n S3W3 131angry adj S3W3 132animal n S1W1 133announce v S2W1 134announcement n S3W3 135annoy v S3N/A 136annual adj S2W2 137another determiner S1W1 138answer n S1W1 139answer v S1W2 140anticipate v S3N/A 141anxiety n S3W3 142anxious adj S3W3 143any determiner S1W1 144any adv S2N/A 145anybody pron S1W3 146anyhow adv S3N/A 147anyone pron S1W1 148anything pron S1W1 149anyway adv S1W2 150anywhere adv S1W3 151apart adv S2W1 152apartment n S2W3 153apologize v S2N/A 154apology n S3N/A 155apparent adj N/A W2 156apparently adv S1W2 157appeal n S2W1 158appeal v S3W3 159appear v S2W1 160appearance n N/A W2 161apple n S2W3162application n S1W1 163apply v S1W1 164appoint v S2W2 165appointment n S2W2 166appreciate v S2W3 167approach v S2W2 168approach n S2W1 169appropriate adj S2W1 170approval n S2W3 171approve v S3W2 172approximate adj S3W3 173architect n N/A W3 174architecture n S3W3 175area n S1W1 176argue v S2W1 177argument n S1W1 178arise v S3W2 179arm n S1W1 180armed adj S3W3 181army n S1W1 182around adv S1W1 183arrange v S2W2 184arrangement n S2W2 185arrest v N/A W3 186arrival n N/A W3 187arrive v S2W1 188art n S1W1 189article n S2W1 190artificial adj S3N/A 191artist n S3W2 192as prep S1W1 193as conjunction S1W1 194ashamed adj S3N/A 195aside adv S3W3 196ask v S1W1 197asleep adj S2N/A 198aspect n S2W1 199assess v S2W2 200assessment n S3W2 201assignment n S2N/A 202assist v S3W3 203assistance n S3W2 204assistant n S3N/A 205associate v S3W2 206association n S3W1 207assume v S2W1 208assumption n S2W2 209assure v S2W3 210at prep S1W1 211atmosphere n S3W2 212attach v S2W2 213attack n S2W2 214attack v S3W2 215attempt n S2W1216attempt v S2W2 217attend v S2W2 218attention n S2W1 219attitude n S2W1 220attorney n S2W3 221attract v S2W2 222attraction n N/A W3 223attractive adj S2W2 224audience n S2W2 225aunt n S3W3 226author n N/A W2 227authority n N/A W1 228automatic adj S3N/A 229automatically adv S3W3 230autumn n N/A W3 231available adj S1W1 232average adj S2W2 233average n S2N/A 234avoid v S2W1 235awake adj S3N/A 236award n S3W2 237award v N/A W3 238aware adj S1W1 239awareness n N/A W3 240away adv S1W1 241awful adj S1N/A 242awkward adj S3N/A 243baby n S1W1 244back adv S1W1 245back n S1W1 246back v S2W3 247back adj S2W3 248background n S2W2 249backwards adv S3N/A 250bacon n S3N/A 251bad adj S1W1 252badly adv S3W3 253bag n S1W2 254bake v S3N/A 255balance n S2W2 256balance v S3N/A 257ball n S1W2 258ban n N/A W3 259band n S2W2 260bang n S3N/A 261bang v S3N/A 262bank n S1W1 263bar n S1W1 264barrier n N/A W3 265base v S1W1 266base n S2W2 267baseball n S3W2 268basic adj S2W1 269basically adv S1N/A270basis n S2W1 271basket n S3N/A 272bat n S3N/A 273bath n S2W3 274bathroom n S2W3 275battery n S2N/A 276battle n N/A W2 277be auxiliary verb S1W1 278be v S1W1 279beach n S2W2 280bean n S2N/A 281bear v S2W2 282beard n S3N/A 283beat v S2W2 284beat n S3N/A 285beautiful adj S1W2 286beauty n S3W2 287because conjunction S1W1 288because prep S1W1 289become v S1W1 290bed n S1W1 291bedroom n S1W2 292beef n S3N/A 293beer n S2W3 294before conjunction S1W1 295before prep S1W1 296before adv S1W1 297beforehand adv S3N/A 298begin v S1W1 299beginning n S1W2 300behalf n S3W3 301behave v S3W3 302behaviour n S2W1 303behind prep S1W1 304being n S2W3 305belief n S3W2 306believe v S1W1 307bell n S2W3 308belong v S2W2 309below adv S2W2 310belt n S2W3 311bench n S2W3 312bend v S3W3 313beneath adv N/A W2 314benefit n S2W1 315benefit v S2W3 316beside prep S3W2 317best adj S1W1 318best adv S1W2 319bet v S1N/A 320bet n S3N/A 321better adj S1W1 322better adv S1W1 323between adv S1W1324beyond prep S2W1 325bicycle n N/A W3 326bid n N/A W3 327big adj S1W1 328bike n S2N/A 329bill n S1W1 330bin n S2N/A 331bird n S2W2 332birth n S2W2 333birthday n S1W3 334biscuit n S2N/A 335bit adv S1W1 336bit n S1W1 337bite v S2N/A 338bite n S3N/A 339bitter adj S3W3 340black adj S1W1 341blade n S3N/A 342blame v S2W3 343blank adj S3N/A 344bless v S3N/A 345blind adj S2W3 346block n S2W2 347block v S3N/A 348bloke n S2N/A 349blonde adj S3N/A 350blood n S2W1 351blow v S2W3 352blow n S3W3 353blue adj S1W2 354board n S1W1 355boat n S1W2 356body n S1W1 357boil v S3N/A 358boiler n S3N/A 359boiling adj, adv S3N/A 360bomb n S3W3 361bone n S2W2 362bonus n S2N/A 363book n S1W1 364book v S2N/A 365boom n S3N/A 366boot n S2W3 367border n S3W2 368bored adj S3N/A 369boring adj S2N/A 370born v S1W2 371borrow v S2W3 372boss n S2W3 373both determiner S1W1 374bother v S1W3 375bottle n S1W2 376bottom n S1W3 377bottom adj S1W3378bounce v S3N/A 379bound adj S2W3 380bowl n S2W3 381box n S1W1 382boy n S1W1 383boyfriend n S3N/A 384brain n S2W2 385branch n S2W2 386brave adj S3N/A 387bread n S2W3 388break v S1W1 389break n S2W2 390breakfast n S2W2 391breast n S3N/A 392breath n S3W2 393breathe v S3W3 394brick n S2W3 395bridge n S2W2 396brief adj S2W2 397briefly adv S2W3 398bright adj S2W2 399brilliant adj S2W3 400bring v S1W1 401broad adj S2W2 402brother n S1W1 403brown adj S2W2 404brush n S3N/A 405brush v S3N/A 406buck n S1N/A 407bucket n S2N/A 408buddy n S3N/A 409budget n S1W2 410bug n S3N/A 411build v S1W1 412builder n S3N/A 413building n S1W1 414bump v S3N/A 415bunch n S2N/A 416burn v S2W3 417burn n S3N/A 418burst v N/A W3 419bury v N/A W3 420bus n S1W2 421business n S1W1 422busy adj S1W2 423but conjunction S1W1 424but prep S2W3 425but adv S2W3 426butcher n S3N/A 427butter n S2N/A 428button n S2N/A 429buy v S1W1 430buyer n S3W3 431by prep S1W1432by adv S1W1 433bye interjection S1N/A 434bye n S3N/A 435cabinet n S2W2 436cable n N/A W3 437cake n S2W3 438calculate v S2W3 439calculation n S2N/A 440calculator n S3N/A 441calendar n S3N/A 442call v S1W1 443call n S1W1 444calm adj S3W3 445camera n S2W3 446camp n S3W3 447campaign n S2W1 448can modal verb S1W1 449can n S2N/A 450cancel v S2N/A 451cancer n S2W2 452candidate n N/A W2 453candle n S3N/A 454candy n S3N/A 455cap n S3N/A 456capable adj S2W2 457capacity n S3W2 458capital n S3W1 459capital adj S2W3 460captain n N/A W3 461capture v N/A W3 462car n S1W1 463card n S1W2 464care n S1W1 465care v S1W2 466career n S2W2 467careful adj S1W2 468carefully adv S2W2 469carpet n S2W3 470carrot n S3N/A 471carry v S1W1 472cartoon n S3N/A 473case n S1W1 474cash n S2W2 475cash v S3N/A 476cast v N/A W3 477castle n N/A W3 478cat n S1W3 479catalogue n N/A W3 480catch v S1W1 481category n S2W2 482cause n S2W1 483cause v S1W1 484CD n S3W3 485cease v N/A W3486ceiling n S3W3 487celebrate v N/A W3 488celebration n S3N/A 489cell n S3W2 490cellphone n S2W3 491cent n S1W1 492centimetre n S3W3 493central adj S1W1 494centre n S1W1 495century n S2W1 496cereal n S3N/A 497certain adj S1W1 498certainly adv S1W1 499certificate n S3W3 500chain n S3W2 501chair n S1W2 502chairman n S3W1 503challenge n S2W2 504challenge v S3W3 505champion n N/A W3 506championship n N/A W3 507chance n S1W1 508change v S1W1 509change n S1W1 510channel n S3W2 511chap n S2N/A 512chapter n S3W1 513character n S1W1 514characteristic n S3W2 515characterize v N/A W3 516charge n S1W1 517charge v S1W2 518charity n S3W3 519chart n S3W3 520chase v S3N/A 521chat n S2N/A 522cheap adj S1W2 523cheat v S3N/A 524check v S1W2 525check n S1W3 526cheek n N/A W3 527cheese n S2W3 528chemical n S3W3 529chemical adj N/A W3 530chemist n S3N/A 531chemistry n S2N/A 532cheque n S2N/A 533cherry n S3N/A 534chest n S2W3 535chicken n S2N/A 536chief adj S2W2 537chief n N/A W3 538child n S1W1 539childhood n N/A W3540chip n S2W3 541chocolate n S2N/A 542choice n S1W1 543choose v S1W1 544chop v S3N/A 545chuck v S3N/A 546church n S1W1 547cigarette n S2W3 548cinema n S3N/A 549circle n S2W2 550circuit n N/A W3 551circumstance n S2W1 552citizen n S2W2 553city n S1W1 554civil adj S3W2 555claim v S1W1 556claim n S2W1 557class n S1W1 558classic adj N/A W3 559classical adj N/A W3 560classroom n S3W3 561clean adj S2W2 562clean v S1W3 563cleaner n S3N/A 564clear adj S1W1 565clear v S1W2 566clearly adv S1W1 567clerk n S3N/A 568clever adj S2N/A 569click v S3N/A 570client n S2W1 571climate n N/A W3 572climb v N/A W2 573clock n S2W3 574close v S1W1 575close adj S1W1 576close adv S2W2 577closed adj S3N/A 578closely adv S3W2 579closet n S3N/A 580cloth n S3N/A 581clothes n S2W2 582cloud n S3W3 583club n S1W1 584clue n S2N/A 585coach n S3W2 586coal n S2W2 587coast n S3W2 588coat n S2W3 589code n S2W2 590coffee n S1W2 591coin n S3N/A 592cold adj S1W1 593collapse v S3N/A594collar n S3N/A 595colleague n S2W2 596collect v S1W2 597collection n S2W1 598college n S1W2 599colour n S1W1 600column n S3W2 601combination n S3W2 602combine v S3W2 603come v S1W1 604comfort n N/A W3 605comfortable adj S2W3 606command n N/A W3 607comment n S1W2 608comment v S3W3 609commercial adj S3W2 610commission n S3W2 611commit v S2W2 612commitment n S2W2 613committee n S3W1 614common adj S1W1 615communicate v S3W3 616communication n S2W1 617community n S1W1 618company n S1W1 619compare v S1W1 620comparison n S3W2 621compete v S3W3 622competition n S2W1 623competitive adj S3W3 624complain v S2W3 625complaint n S3W3 626complete adj S2W1 627complete v S2W1 628completely adv S1W2 629complex adj S3W2 630complicated adj S2N/A 631component n N/A W2 632comprehensive adj N/A W3 633comprise v N/A W3 634computer n S1W1 635concentrate v S2W2 636concentration n S3W2 637concept n S3W2 638concern n S1W1 639concern v N/A W3 640concerned adj S1W1 641concerning prep N/A W3 642concert n S3W3 643conclude v S3W2 644conclusion n S3W2 645condition n S2W1 646conduct v N/A W2 647conduct n N/A W3648conference n S2W1 649confidence n S2W2 650confident adj S3W3 651confine v N/A W3 652confirm v S2W2 653conflict n S3W2 654confused adj S3N/A 655confusing adj S3N/A 656confusion n S3W3 657congratulation n S3N/A 658connect v S2W2 659connection n S3W2 660conscious adj S2W3 661consciousness n N/A W3 662consent n N/A W3 663consequence n S3W2 664consider v S1W1 665considerable adj S3W1 666considerably adv S3N/A 667consideration n S2W2 668consist v N/A W3 669consistent adj S3W3 670constant adj S3W3 671constantly adv S3W3 672constitute v N/A W3 673construct v N/A W3 674construction n S3W2 675consult v S3W3 676consumer n S3W2 677consumption n N/A W3 678contact n S2W2 679contact v S2W2 680contain v S2W1 681contemporary adj N/A W2 682content n S3W2 683contest n N/A W3 684context n S2W2 685continue v S1W1 686continuous adj S3W3 687contract n S1W1 688contrast n N/A W2 689contribute v S3W2 690contribution n S2W2 691control n S1W1 692control v S2W1 693convenient adj S3N/A 694convention n N/A W2 695conventional adj N/A W3 696conversation n S1W2 697convert v N/A W3 698conviction n N/A W3 699convince v S3W3 700cook v S1W3 701cooker n S3N/A702cookie n S3W3 703cool adj S2W3 704cool v S2N/A 705cooperation n S3W3 706cope v S2W3 707copy n S1W2 708copy v S2N/A 709core n N/A W3 710corn n S3N/A 711corner n S1W2 712correct adj S1W2 713correct v S3N/A 714corridor n S2W3 715cost n S1W1 716cost v S1W2 717cottage n S3W3 718cotton n N/A W3 719could modal verb S1W1 720council n S2W2 721count v S2W3 722counter n S3N/A 723country n S1W1 724countryside n S3W3 725county n N/A W2 726couple n S1W1 727courage n S3N/A 728course n S1W1 729court n S1W1 730cousin n S2N/A 731cover v S1W1 732cover n S1W2 733cow n S2N/A 734crack v S3N/A 735craft n N/A W3 736crash n S3N/A 737crazy adj S2N/A 738create v S2W1 739creation n N/A W2 740creative adj N/A W3 741creature n N/A W3 742credit n S2W2 743credit card n S3W3 744crew n S3W3 745crime n S2W2 746criminal adj S3W2 747crisis n S3W2 748criterion n N/A W2 749critic n N/A W3 750critical adj S3W2 751criticism n S3W2 752criticize v N/A W3 753crop n N/A W3 754cross v S2W2 755cross n S3W3756cross adj S2N/A 757crowd n S3W2 758crown n N/A W3 759crucial adj N/A W2 760cruel adj S3N/A 761cry v S2W2 762cry n N/A W3 763cultural adj N/A W2 764culture n S2W1 765cup n S1W1 766cupboard n S2N/A 767curious adj S3N/A 768currency n N/A W2 769current adj S2W2 770current n N/A W3 771currently adv S2W2 772curtain n S3W3 773curve n S3W3 774cushion n S3N/A 775custom n N/A W3 776customer n S1W1 777cut v S1W1 778cut n S2W2 779cute adj S2N/A 780cycle n S3W3 781dad n S1W3 782daddy n S1N/A 783daft adj S3N/A 784daily adj S3W2 785damage n S3W2 786damage v S3W3 787dance n S2W3 788dance v S2W3 789danger n S2W2 790dangerous adj S2W2 791dare v S3W3 792dark adj S2W1 793darkness n N/A W3 794darling n S2N/A 795data n S1W1 796database n S3W3 797date n S1W1 798date v S3W3 799daughter n S1W1 800day n S1W1 801dead adj S1W1 802dead adv S3N/A 803deaf adj N/A W3 804deal n S1W1 805deal v S1W1 806dealer n N/A W3 807dear interjection S1N/A 808dear n S2N/A 809dear adj S2W2810death n S1W1 811debate n S2W2 812debt n S3W2 813decade n N/A W2 814decent adj S3N/A 815decide v S1W1 816decision n S1W1 817declare v N/A W2 818decline n N/A W2 819decline v N/A W3 820deep adj S2W1 821deep adv N/A W3 822deeply adv N/A W3 823defeat n N/A W3 824defeat v N/A W3 825defence n S2W1 826defend v S3W3 827define v S2W2 828definite adj S3N/A 829definitely adv S1N/A 830definition n S2W2 831degree n S2W1 832delay n N/A W3 833delay v N/A W3 834deliberately adv S3N/A 835deliver v S2W2 836delivery n S3W3 837demand n S2W1 838demand v N/A W2 839democracy n N/A W2 840democratic adj N/A W2 841demonstrate v S3W2 842demonstration n N/A W3 843dentist n S3N/A 844deny v S3W2 845department n S2W1 846departure n N/A W3 847depend v S1W2 848dependent adj N/A W3 849deposit n S3W3 850depression n N/A W3 851depth n S3W3 852derive v N/A W3 853describe v S2W1 854description n S2W2 855desert n N/A W3 856deserve v S3W3 857design n S2W1 858design v S3W1 859designer n N/A W3 860desire n N/A W2 861desk n S2W2 862desperate adj S3W3 863despite prep S3W1864destroy v S2W2 865destruction n N/A W3 866detail n S2W1 867detailed adj N/A W2 868detect v N/A W3 869determination n N/A W3 870determine v N/A W2 871determined adj N/A W3 872develop v S2W1 873development n S1W1 874device n S3W2 875devil n S3N/A 876diagram n S3N/A 877diamond n S3N/A 878diary n S3N/A 879die v S1W1 880diet n S3W2 881differ v N/A W3 882difference n S1W1 883different adj S1W1 884difficult adj S1W1 885difficulty n S2W1 886dig v S2N/A 887dimension n N/A W3 888dinner n S1W2 889direct adj S2W1 890direct v S3W2 891direction n S1W1 892directly adv S2W2 893director n S2W1 894directory n S3N/A 895dirt n S3N/A 896dirty adj S2W3 897disabled adj S3W3 898disagree v S3N/A 899disappear v S2W2 900disappoint v N/A W3 901disappointed adj S3W3 902disaster n S3W3 903disc n S2W3 904discipline n S3W3 905discount n S3N/A 906discover v S2W1 907discovery n N/A W3 908discuss v S2W1 909discussion n S2W1 910disease n S3W1 911disgusting adj S2N/A 912dish n S2W3 913disk n S2W3 914dismiss v N/A W3 915display n S3W2 916display v N/A W2 917dispute n N/A W2918distance n S2W2 919distant adj N/A W3 920distinct adj N/A W3 921distinction n N/A W3 922distinguish v S3W3 923distribute v N/A W2 924distribution n N/A W2 925district n S3W2 926disturb v N/A W3 927divide v S2W2 928division n S3W1 929divorce n S3N/A 930do auxiliary verb S1W1 931do v S1W1 932doctor n S1W1 933document n S2W2 934dog n S1W1 935dollar n S1W2 936domestic adj N/A W2 937dominant adj N/A W3 938dominate v N/A W3 939door n S1W1 940dot n S2N/A 941double adj S1W2 942double v S3N/A 943doubt n S1W1 944doubt v S2N/A 945down adv S1W1 946downstairs adv S2N/A 947downtown adv S3W3 948dozen number S2W3 949draft n S2W3 950drag v S3W3 951drama n N/A W3 952dramatic adj N/A W3 953draw v S1W1 954draw n S3N/A 955drawer n S3N/A 956drawing n S3W3 957dream n S2W2 958dream v S3W3 959dress n S2W2 960dress v S2W2 961drink v S1W2 962drink n S1W2 963drive v S1W1 964drive n S2W2 965driver n S1W2 966drop v S1W2 967drop n S2W3 968drug n S2W1 969drunk adj S3N/A 970dry adj S2W2 971dry v S2W3972duck n S3N/A 973dude n S3N/A 974due adj S1W1 975dull adj S3N/A 976dumb adj S3N/A 977dump v S3N/A 978during prep S1W1 979dust n S3W3 980duty n S2W1 981DVD n S3W3 982each determiner S1W1 983each other pron S1W1 984ear n S2W2 985early adj S1W1 986early adv S1W1 987earn v S2W2 988earth n S2W2 989ease v N/A W3 990easily adv S2W1 991east n S1W2 992eastern adj S2W2 993easy adj S1W1 994easy adv S2N/A 995eat v S1W1 996economic adj S2W1 997economics n N/A W3 998economy n S2W1 999edge n S2W2 1000edition n N/A W3 1001editor n N/A W2 1002education n S1W1 1003educational adj S3W2 1004effect n S1W1 1005effective adj S2W1 1006effectively adv S3W2 1007efficiency n N/A W3 1008efficient adj S3W3 1009effort n S1W1 1010egg n S1W2 1011either conjunction S1W1 1012either determiner S1W1 1013elderly adj S3W2 1014elect v S3W3 1015election n S2W1 1016electric adj S2W3 1017electrical adj S3N/A 1018electricity n S2W3 1019electronic adj S3W3 1020element n S2W1 1021elevator n S3W3 1022else adv S1W1 1023elsewhere adv S3W2 1024email n S2W2 1025email v S2W21026embarrassed adj S3N/A 1027emerge v N/A W2 1028emergency n S3W3 1029emotion n N/A W3 1030emotional adj S3W3 1031emphasis n S3W2 1032emphasize v S3W2 1033empire n N/A W3 1034employ v S3W2 1035employee n S2W2 1036employer n S2W2 1037employment n S2W1 1038empty adj S2W2 1039enable v S3W1 1040encounter v N/A W3 1041encourage v S2W1 1042encouraging adj S3N/A 1043end n S1W1 1044end v S1W1 1045enemy n N/A W2 1046energy n S2W1 1047engage v N/A W3 1048engine n S2W2 1049engineer n S3W3 1050engineering n S3W3 1051enhance v N/A W3 1052enjoy v S1W1 1053enjoyable adj S3N/A 1054enormous adj S2W3 1055enough adv S1W1 1056enough determiner S1W2 1057enquiry n S2W2 1058ensure v S2W1 1059enter v S2W1 1060enterprise n N/A W2 1061entertainment n S3W3 1062enthusiasm n N/A W3 1063enthusiastic adj S3N/A 1064entire adj S3W2 1065entirely adv S2W2 1066entitle v S3W3 1067entrance n S3W3 1068entry n S3W2 1069envelope n S3N/A 1070environment n S1W1 1071environmental adj S2W2 1072equal adj S1W2 1073equal v S2N/A 1074equally adv S3W2 1075equipment n S2W2 1076equivalent adj N/A W3 1077era n N/A W3 1078error n S3W2 1079escape v S3W21080escape n S3N/A 1081especially adv S1W1 1082essay n S3N/A 1083essential adj S3W2 1084essentially adv S2W3 1085establish v S2W1 1086establishment n N/A W2 1087estate n S2W2 1088estimate n S3W2 1089estimate v S3W2 1090ethnic adj N/A W3 1091even adv S1W1 1092evening n S1W1 1093event n S1W1 1094eventually adv S1W2 1095ever adv S1W1 1096every determiner S1W1 1097everybody pron S1W3 1098everyone pron S1W1 1099everything pron S1W1 1100everywhere adv S2W3 1101evidence n S2W1 1102evil adj S3W3 1103exact adj S3N/A 1104exactly adv S1W2 1105exam n S1N/A 1106examination n N/A W2 1107examine v S3W2 1108example n S1W1 1109excellent adj S1W2 1110except conjunction S2W2 1111exception n S3W2 1112exchange n S2W1 1113excitement n S3W3 1114exciting adj S2W3 1115exclude v N/A W3 1116excuse v S1N/A 1117excuse n S3N/A 1118executive n S3W2 1119executive adj N/A W3 1120exercise n S2W2 1121exercise v S3W2 1122exhibition n N/A W2 1123exist v S2W1 1124existence n S3W2 1125existing adj S2W2 1126exit n S3N/A 1127expand v S3W3 1128expansion n N/A W3 1129expect v S1W1 1130expectation n S3W2 1131expenditure n N/A W2 1132expense n S3W2 1133expensive adj S1W21134experience n S1W1 1135experience v S2W2 1136experienced adj S3N/A 1137experiment n S3W2 1138experimental adj N/A W3 1139expert n S3W2 1140expert adj N/A W3 1141explain v S1W1 1142explanation n S3W2 1143explore v S3W2 1144explosion n N/A W3 1145export n N/A W2 1146expose v N/A W3 1147express v S2W1 1148expression n S2W2 1149extend v S3W2 1150extension n S3W3 1151extensive adj N/A W3 1152extent n S2W1 1153external adj N/A W2 1154extra adj S1W2 1155extraordinary adj S3W3 1156extreme adj S3W3 1157extremely adv S2W2 1158eye n S1W1 1159face n S1W1 1160face v S1W1 1161facility n S2W1 1162fact n S1W1 1163factor n S3W1 1164factory n S2W2 1165fail v S2W1 1166failure n S3W2 1167fair adj S1W2 1168fair adv S2W3 1169fairly adv S1W2 1170faith n S3W2 1171fall v S1W1 1172fall n S2W2 1173false adj N/A W3 1174familiar adj S3W2 1175family n S1W1 1176famous adj S2W2 1177fan n S3W2 1178fancy v S2N/A 1179fancy adj S3N/A 1180fantastic adj S3N/A 1181far adv S1W1 1182far adj S1W1 1183farm n S2W2 1184farmer n S2W2 1185fascinating adj S3N/A 1186fashion n S3W2 1187fast adv S2W31188fast adj S2W2 1189fat adj S2W3 1190father n S1W1 1191fault n S2W3 1192favour n S2W3 1193favour v N/A W3 1194favourite adj S3W3 1195fear n S3W1 1196fear v N/A W2 1197feature n S2W1 1198feature v N/A W3 1199federal adj N/A W1 1200fee n S3W3 1201feed v S1W2 1202feedback n S3N/A 1203feel v S1W1 1204feeling n S1W1 1205fellow adj N/A W3 1206female adj S3W2 1207female n N/A W3 1208fence n S3N/A 1209festival n S3W3 1210fetch v S3N/A 1211few determiner S1W1 1212field n S1W1 1213fight v S1W1 1214fight n S2W3 1215figure n S1W1 1216figure v S1W3 1217file n S1W2 1218file v S3W3 1219fill v S1W1 1220film n S1W1 1221filthy adj S3N/A 1222final adj S1W1 1223finally adv S2W1 1224finance n S3W2 1225finance v N/A W3 1226financial adj S2W1 1227find v S1W1 1228finding n N/A W2 1229fine adj S1W1 1230fine adv S3N/A 1231finger n S2W2 1232finish v S1W2 1233finish n S3N/A 1234fire n S1W1 1235fire v S3W3 1236firm n S1W1 1237firm adj S3W2 1238first adj S1W1 1239first adv S1W2 1240firstly adv S3N/A 1241fish n S1W11242fish v S3N/A 1243fishing n S3N/A 1244fit v S1W2 1245fit adj S2W3 1246fix v S2W2 1247fixed adj S3W3 1248flash v S3N/A 1249flat adj S2W2 1250flat n S2W3 1251flesh n N/A W3 1252flight n S3W2 1253flood v N/A W3 1254floor n S1W1 1255flow n S3W2 1256flow v N/A W3 1257flower n S2W2 1258fly v S2W2 1259focus v S3W2 1260focus n S3W2 1261fold v N/A W3 1262folk n S2W3 1263follow v S1W1 1264following adj S3W1 1265food n S1W1 1266foot n S1W1 1267football n S1W2 1268for prep S1W1 1269force n S2W1 1270force v S2W1 1271foreign adj S3W1 1272forest n S2W2 1273forever adv S2W3 1274forget v S1W1 1275forgive v S3N/A 1276fork n S3N/A 1277form n S1W1 1278form v S2W1 1279formal adj S2W2 1280formally adv S3N/A 1281formation n N/A W3 1282former adj S2W1 1283formula n S3W3 1284forth adv S2N/A 1285fortnight n S3N/A 1286fortunate adj S3N/A 1287fortune n S3W3 1288forward adv S1W1 1289forward adj S2W3 1290foundation n N/A W2 1291frame n S3W3 1292frankly adv S3N/A 1293free adj S1W1 1294free v S3W3 1295freedom n S3W21296freeway n S2W3 1297freeze v S3W3 1298freezer n S3N/A 1299frequent adj N/A W3 1300frequently adv S3W2 1301fresh adj S2W2 1302fridge n S2N/A 1303friend n S1W1 1304friendly adj S2W3 1305friendship n N/A W3 1306frightened adj S3N/A 1307from prep S1W1 1308front n S1W1 1309front adj S1W2 1310fruit n S2W3 1311fry v S3N/A 1312fuel n S3W2 1313fulfil v N/A W3 1314full adj S1W1 1315fully adv S2W2 1316fun n S2W3 1317fun adj S2W3 1318function n S3W1 1319fund n S3W1 1320fund v S3W3 1321fundamental adj N/A W2 1322funeral n S3N/A 1323funny adj S1W3 1324furniture n S2W3 1325further adv S1W1 1326fuss n S3N/A 1327future adj S1W1 1328future n S1W1 1329gain v S3W2 1330gain n N/A W3 1331gallery n N/A W3 1332game n S1W1 1333gang n S3N/A 1334gap n S2W2 1335garage n S2N/A 1336garbage n S3N/A 1337garden n S1W1 1338garlic n S3N/A 1339gas n S1W2 1340gasoline n S3W3 1341gate n S2W2 1342gather v S3W2 1343gay adj S3W3 1344gear n S3N/A 1345gene n S3W3 1346general adj S1W1 1347generally adv S2W1 1348generate v S3W2 1349generation n S3W21350generous adj N/A W3 1351gentle adj S3W3 1352gentleman n S2W2 1353gently adv N/A W3 1354genuine adj S3W3 1355get v S1W1 1356giant adj N/A W3 1357gift n S2W2 1358girl n S1W1 1359girlfriend n S3N/A 1360give v S1W1 1361glad adj S2W3 1362glance n N/A W3 1363glass n S1W1 1364global adj N/A W2 1365glove n S3N/A 1366go v S1W1 1367go n S1N/A 1368goal n S2W1 1369god n S1W1 1370gold n S2W2 1371gold adj S3W3 1372golden adj N/A W3 1373golf n S2W3 1374good adj S1W1 1375goodbye S3N/A 1376good morning interjection S2N/A 1377goodness n S2N/A 1378good night S3N/A 1379goods n S2W2 1380gorgeous adj S3N/A 1381gosh interjection S2N/A 1382govern v N/A W3 1383government n S2W1 1384governor n N/A W3 1385grab v S2W3 1386grade n S2W3 1387gradually adv S3W3 1388gram n S3N/A 1389grammar n S3W3 1390grand adj S2W3 1391grandad n S3N/A 1392grandfather n S3N/A 1393grandma n S2N/A 1394grandmother n S3N/A 1395grandpa n S3N/A 1396granny n S3N/A 1397grant v S2W2 1398grant n S2W2 1399graph n S3N/A 1400grass n S2W2 1401grateful adj S3W3 1402great adj S1W1 1403greatly adv N/A W31404green adj S1W2 1405green n S2W3 1406grey adj S2W2 1407grocery n S3N/A 1408gross adj S3N/A 1409ground n S1W1 1410group n S1W1 1411grow v S1W1 1412growth n S3W1 1413guarantee v S2W3 1414guarantee n S3N/A 1415guard n S3W3 1416guess v S1W3 1417guess n S3N/A 1418guest n S3W2 1419guidance n S3W3 1420guide n S3W2 1421guide v N/A W3 1422guilty adj S2W3 1423guitar n S3W3 1424gun n S2W2 1425guy n S1W3 1426habit n S3W3 1427hair n S1W1 1428half predeterminer S1W1 1429half n S1W2 1430half adv S2N/A 1431halfway adj S3N/A 1432hall n S2W2 1433hand n S1W1 1434hand v S2W2 1435handbag n S3N/A 1436handle v S2W2 1437handle n S3N/A 1438handy adj S3N/A 1439hang v S1W2 1440happen v S1W1 1441happy adj S1W1 1442hard adj S1W1 1443hard adv S1W2 1444hardly adv S2W2 1445harm n S3W3 1446hat n S1W3 1447hate v S1W3 1448have auxiliary verb S1W1 1449have v S1W1 1450have v S1W3 1451he pron S1W1 1452head n S1W1 1453head v S2W2 1454headquarters n N/A W3 1455health n S1W1 1456healthy adj S3W3 1457hear v S1W11458hearing n S3W2 1459heart n S1W1 1460heat n S2W2 1461heat v S3N/A 1462heater n S3N/A 1463heating n S3N/A 1464heaven n S3W3 1465heavily adv N/A W3 1466heavy adj S1W1 1467height n S2W3 1468hell n S1W3 1469hello interjection S1N/A 1470help v S1W1 1471help n S1W1 1472helpful adj S2W3 1473hence adv N/A W3 1474her determiner S1W1 1475her pron S1W1 1476here adv S1W1 1477hero n N/A W3 1478hers pron S3W3 1479herself pron S2W1 1480hesitate v N/A W3 1481hi interjection S1N/A 1482hide v S2W2 1483high adj S1W1 1484high adv S3N/A 1485highlight v N/A W3 1486highly adv S2W2 1487highway n S3N/A 1488hill n S2W2 1489him pron S1W1 1490himself pron S1W1 1491hire v S2W3 1492his determiner S1W1 1493historian n N/A W3 1494historical adj N/A W2 1495history n S2W1 1496hit v S1W2 1497hit n S3W3 1498hold v S1W1 1499hold n S2W3 1500holder n N/A W2 1501holding n N/A W3 1502hole n S1W2 1503holiday n S1W2 1504holy adj N/A W3 1505home n S1W1 1506home adv S1W1 1507homework n S2N/A 1508honest adj S1W3 1509honestly adv S2N/A 1510honey n S2N/A 1511honour n N/A W3。

临床试验专用术语实用小词典中国临床研究专业网 组织翻译制作翻 译Pipidan校对排版素人娱夫责任编辑harry97临床试验专用术语实用小词典会员 Pipidan 翻译 素人娱夫 校对排版简化新药申请（ABBREVIATED NEW DRUG APPLICATION,ANDA） (7)审查异议信件(ACTION LETTER) (7)积极治疗(ACTIVE TREATMENT) (7)辅助治疗(ADJUV ANT) (8)ADME (8)行政视察(ADMINISTRATIVE LOOK) (8)药物不良反应（ADVERSE DRUG REACTION ,ADR） (9)不良经历（ADVERSE EXPERIENCE，AE） (9)咨询委员会（ADVISORY COMMITTEE） (9)修正案（AMENDMENT） (10)递增剂量（ASCENDING DOSE） (10)稽查（AUDIT） (10)稽查跟踪（AUDIT TRAIL） (11)基线（BASELINE） (11)偏差（BIAS） (11)生物利用度（BIOA V AILABILITY） (11)生物等效性（BIOEQUIV ALENCE） (12)生物制药学（BIOPHARMACEUTICAL） (12)BIRA (12)设盲（BLINDING） (12)CANDA (13)病历记录（CASE HISTORY RECORD） (13)病例报告表（CASE REPORT FORM，CRF） (14)因果关系（CAUSALITY） (14)CBER (14)CDER (14)CDRH (15)CFR (15)临床研究（CLINICAL INVESTIGATION） (15)临床研究者（CLINICAL INVESTIGATOR） (15)临床研究助理（CLINICAL RESEARCH ASSOCIATE，CRA） (16)临床研究协调员（CLINICAL RESEARCH COORDINATOR，CRC） (16)临床研究协议（CLINICAL STUDY AGREEMENT，CSA） (16)临床试验（CLINICAL TRIAL） (17)减免临床试验[CLINICAL TRIAL EXEMPTION，CT(X)] (18)盲码破译信封（CODE BREAKER） (18)合作研究者/次级研究者（COINVESTIGATOR/SUBINVESTIGATOR） (18)联合治疗（COMBINATION THERAPY） (19)慈善用药（COMPASSIONATE USE） (19)依从性（COMPLIANCE） (19)验证性研究（CONFIRMATORY STUDY） (19)合同（CONTRACT） (20)合同研究组织（CONTRACT RESEARCH ORGANIZATION,CRO） (20)禁忌症(CONTRAINDICATION) (21)对照组(CONTROL GROUP) (21)对照临床试验(CONTROLLED CLINICAL TRIAL) (21)协调中心(COORDINATING CENTER) (22)协调研究者(COORDINATING INVESTIGATOR) (22)交叉设计(CROSSOVER DESIGN) (22)简历（CURRICULUM VITAE,CV） (22)数据(DATA) (22)资料安全监测委员会 (23)2（DATA AND SAFETY MONITORING BOARD,DSMB） (23)数据核查(DATA AUDIT) (23)数据编辑(DATA EDIT) (23)数据管理(DATA MANAGEMENT) (24)赫尔辛基宣言(DECLARATION OF HELSINKI) (24)DHHS (24)文件(DOCUMENTATION) (24)剂量限制性毒性(DOSE-LIMITING TOXICITY) (25)剂量范围研究(DOSE-RANGING STUDIES) (25)双盲(DOUBLE BLIND) (25)脱落病例(DROPOUT) (25)DSMB (25)EC (26)有效性(EFFICACY) (26)EFPIA (26)EMEA (26)终点(ENDPOINT) (26)伦理委员会（EC） (27)EU (27)可评价患者(EV ALUABLE PATIENT) (27)总结报告（研究者提供）[FINAL REPORT (by Investigator)] (28)研究总结报告（FINAL STUDY REPORT） (28)美国食品药品管理局（FOOD AND DRUG ADMINISTRATION,FDA） (28)药物临床试验质量管理规范（GOOD CLINICAL PRACTICE,GCP） (29)实验室质量管理规范（GOOD LABORATORY PRACTICE,GLP） (29)药品生产质量管理规范（GOOD MANUFACTURING PRACTICE,GMP）..29赫尔辛基宣言(HELSINKI, DECLARATION OF) (30)ICH (30)3IDE (30)IDMC (30)赔偿(INDEMNIFICATION) (30)适应症(INDICATION) (31)信息修订(INFORMATION AMENDMENT) (31)知情同意书(INFORMED CONSENT FORM) (31)视察(INSPECTION) (32)机构审查委员会（INSTITUTIONAL REVIEW BOARD,IRB） (32)试验药物或产品(INVESTIGATIONAL AGENT OR PRODUCT) (33)研究性新药(INVESTIGATIONAL NEW DRUG) (33)新药研究（IND）申请 (33)INVESTIGATIONAL NEW DRUG (IND) APPLICATION (33)研究者（主要研究者）INVESTIGATOR (Principal Investigator) (34)研究者手册(INVESTIGATOR'S BROCHURE) (34)实验室证明(LABORATORY CERTIFICATION) (35)上市许可申请（MARKETING AUTHORIZATION APPLICATION,MAA）..35最大耐受剂量（MAXIMUM TOLERATED DOSE ,MTD） (36)监查员(MONITOR) (36)监查(MONITORING) (36)MOU (36)多中心试验(MULTICENTER TRIAL) (37)新药申请（NEW DRUG APPLICATION,NDA） (37)新分子实体（NEW MOLECULAR ENTITY,NME） (37)NIH (37)非临床研究(NONCLINICAL STUDIES) (38)开放性研究(OPEN LABEL STUDY) (38)OHRP (38)结果(OUTCOME) (38)4药品说明书(PACKAGE INSERT) (38)平行研究设计(PARALLEL STUDY DESIGN) (39)患者信息表(PATIENT INFORMATION SHEET) (39)药品(PHARMACEUTICAL PRODUCT) (39)药效学（PHARMACODYNAMICS ,PD） (40)药代动力学（PHARMACOKINETICS,PK） (40)药物经济学研究(PHARMACOECONOMIC STUDY) (40)药物流行病学(PHARMACOEPIDEMIOLOGY) (40)药理学(PHARMACOLOGY) (41)I期临床(PHASE I) (41)II期临床(PHASE I1) (41)Ⅲ期临床(PHASE I11) (42)Ⅳ期临床(PHASE IV) (42)安慰剂(PLACEBO) (43)PMA (43)上市后监测(POSTMARKETING SURVEILLANCE) (43)临床前研究(PRECLINICAL STUDIES) (43)主要研究者(PRINCIPAL INVESTIGATOR) (44)方案(PROTOCOL) (44)方案-详细（计划）行政视察 (44)(PROTOCOL-SPECIFIED (PLANNED) ADMINISTRATIVE LOOK) (44)随机化(RANDOMIZATION) (45)随机码(RANDOMIZATION CODE) (45)区域临床研究助理 (45)（REGIONAL CLINICAL RESEARCH ASSOCIATER,CRA） (45)风险-收益比(RISK-BENEFIT RATIO) (46)安全性(SAFETY) (46)严重不良事件（SERIOUS ADVERSE EXPERIENCE,SAE） (46)5副作用(SIDE EFFECT) (47)单盲(SINGLE BLIND) (47)原始数据(SOURCE DATA) (47)源文件(SOURCE DOCUMENT) (47)源文件核查(SOURCE DOCUMENT VERIFICATION) (48)申办者(SPONSOR) (48)申办者-研究者(SPONSOR-INVESTIGATOR) (49)入组(STAGING) (49)标准操作规程(STANDARD OPERATING PROCEDURE) (49)标准治疗(STANDARD TREATMENT) (49)研究者声明（SOI）表（即FDA 1572表格） (50)分层(STRATA/STRATIFICATION) (50)研究组(STUDY ARM) (50)研究协调员(STUDY COORDINATOR) (50)研究药物(STUDY DRUG) (51)研究档案(STUDY FILES) (51)次级研究者/合作研究者(SUBINVESTIGATOR/COINVESTIGATOR) (51)受试者(SUBJECT) (52)替代指标(SURROGATE OUTCOME) (52)可揭标签(TEAR-OFF LABELS) (53)治疗方法(THERAPEUTIC) (53)毒理学(TOXICOLOGY) (53)治疗组(TREATMENT GROUP) (53)试验新药用于治疗(TREATMENT INVESTIGATIONAL NEW DRUG) (53)三盲(TRIPLE BLIND) (54)非对照(UNCONTROLLED) (54)非预期的不良事件(UNEXPECTED ADVERSE EXPERIENCE) (54)非计划性行政视察(UNPLANNED ADMINISTRATIVE LOOK) (55)6WHO (55)简化新药申请（ABBREVIATED NEW DRUG APPLICATION,ANDA）参考其他新药申请数据的新药申请简略版。

·专家论坛·研究者发起的临床研究质量管理体系建设张卿1 高源1 黄轶刚2 张长青2 张力1（1. 同济大学附属同济医院临床研究中心 上海 200065；2. 上海交通大学医学院附属第六人民医院骨科 上海 200233）摘 要 我国研究者发起的临床研究（investigator-initiated trial, IIT ）数量持续增加，同时其研究质量问题也逐渐凸显。

如何建设和优化医疗卫生机构IIT 质量管理体系，提升研究质量，成为医疗卫生机构管理者关注的焦点之一。

本文梳理国际/我国质量管理标准，结合IIT 质量管理实践，提出应将质量管理的基本原则、要求和方法应用于医疗卫生机构IIT 质量管理体系建设。

医疗卫生机构管理者须根据IIT 的特点建设与IIT 相适宜的质量管理体系，以保障受试者的权益和安全，确保研究数据的真实性和可靠性。

关键词 研究者发起的临床研究 质量管理体系 质量管理标准中图分类号：R197; R951 文献标志码：C 文章编号：1006-1533(2024)05-0009-05引用本文 张卿, 高源, 黄轶刚, 等. 研究者发起的临床研究质量管理体系建设[J]. 上海医药, 2024, 45(5): 9-13; 76.The construction of quality management system for investigator-initiated trialsZHANG Qing 1, GAO Yuan 1, HUANG Yigang 2, ZHANG Changqing 2, ZHANG Li 1(1. Clinical Research Center, Tongji Hospital, Tongji University, Shanghai 200065, China; 2. Department of Orthopedics,Shanghai Sixth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China)ABSTRACT The number of investigator-initiated trial (IIT) has increased continuously in our country and meanwhile the quality of their studies is gradually becoming prominent. How to construct and optimize quality management system (QMS) of IIT and improve IIT quality has become one of the focuses of managers in the medical and health institutions. This article sorts out international and domestic quality management standards including principles, requirements and methods, analyzes the application in the IIT-QMS construction, and proposes applicability, reference significance and specificity of the quality management standards for IIT-QMS construction. These standards would guide medical and health institutions to construct the effective QMS in order to ensure the rights and safety of subjects and the authenticity and reliability of research data.KEY WORDS investigator-initiated trial; quality management system; quality management standards基金项目：上海市卫生健康委员会卫生健康政策研究课题（2023HP40）；上海申康医院发展中心“临床三年行动计划”项目（SHDC2022CRS048、SHDC2023CRS030）；上海申康医院发展中心管理研究项目（2023SKMR -30）；上海市科学技术委员会“科技创新行动计划”软科学研究项目（23692113100）作者简介：张卿，博士，副研究员。