简述临床监查员的工作职责和工作流程Word格式文档下载.docx

1、临床启动方案；临床监查方案；临床统计方案；临床总结方案；临床费用预算；可能出现的问题与解决方法。2准备研究者手册通过查阅相关专业文献资料，临床监查员负责编写研究者手册。主要内容包括：背景资料；化学资料；药学资料；药理毒理学资料；临床与对照药相关资料、相关文献等。3选择临床单位包括牵头单位拜访拟定各临床单位，并考察其：合作态度、团队精神；人员资格、数量、工作经验；试验场所、床位；临床试验检查仪器和设备；日门诊量等。在充分考察上述条件的根底上，选定牵头和临床参加单位。4选择统计单位通过多种渠道详细了解并核实：统计单位资质条件专业根底与人员配备组成等；合作态度；工作效率；工作程序等。在充分考察上述条

2、件的根底上，选定临床统计单位。5起草临床方案并设计CRF表监查员独立或会同主要研究者拟定临床方案草案；监查员根据临床方案设计CRF表草案。6召开临床协调会与各临床中心协商确定临床协调会召开时间和地点；拟定会议工作安排与分工；准备临床协调会相关资料技术资料、会议签到表、准备研究者签名样张等；召开协调会并讨论临床方案与相关问题。7修订临床方案与CRF表根据临床协调会意见，由监查员负责修订临床方案与CRF表，并经主要研究者同意后确定。8申请伦理委员会通过准备伦理委员会开会资料，包括：临床研究批件；临床研究方案；CRF表；临床研究者手册；知情同意书样本；临床样品检验报告单。将上述资料整理并提交牵头医院

3、伦理委员会，同时缴纳一定伦理委员会咨询费用，即可申请伦理委员召开会议并讨论通过。9SFDA备案准备以下相关备案资料：临床研究参加机构名称与研究者姓名；伦理委员会审核同意书；知情同意书样本。将上述资料整理齐备后，提交国药局与各临床单位所在地省级药监局备案。10签订临床研究协议监查员起草与各临床中心研究协议，并经公司和医院双方同意后签订协议。11印制正式CRF表临床监查员同印刷厂家一起印制并校对正式三联无炭复写CRF表。12准备临床样品根据临床试验类型随机或双盲等方案临床样品数量和包装形式；做方案购置对照药品；设计各种规格临床研究用样品标签；设计各种大小临床样品包装盒；协助统计专家编制随机表；协助

4、统计专家对临床样品编盲；填写盲底交接记录表。13发放临床样品将临床药品发放各临床中心并填写交接记录；同时发放临床研究者手册、临床方案、正式CRF表。14对研究者进行培训监查员分别召集各临床中心研究者，对其进行相关药政法规与临床方案和CRF表知识培训；对各临床中心提出的问题进行答疑。15获得各中心临床检测正常值范围对所有临床研究中涉与的临床实验室检查均要取得各中心正常值范围；对各中心不同正常值范围进行调查核实；将此正常值范围表提交临床统计单位。16拟定招募受试者广告如采用，那么监查员应负责起草与处理张贴招募受试者广告相关事宜。临床试验进行阶段17制定访视方案制定访视时间表；制定CRF表收集方案；

5、将上述方案明确告知各临床中心。18临床质量控制监查员监查研究者对试验方案的执行情况；确认在试验前取得所有受试者的知情同意书；了解受试者的入选率与试验的进展状况；确认入选的受试者合格；确认所有数据的记录与报告正确完整，所有病例报告表填写正确，并与原始资料一致；所有错误或遗漏均已改正或注明，经研究者签名并注明日期；确认每一受试者的剂量改变、治疗变更、合并用药、伴发疾病、失访、检查遗漏等均确认并记录；确认入选受试者的退出与失访均已在病例报告表中予以说明；确认所有不良事件均记录在案，严重不良事件在规定时间内作出报告并记录在案；核实试验用药品按照有关法规进行供应、储藏、分发、收回，并做相应的记录；协助研

6、究者进行必要的通知与申请事宜；监查并如实记录研究者未能做到的随访、未进行的试验、未做的检查，以与是否对错误、遗漏作出纠正；监查员每次访视后均要作一书面报告递送研究者，报告应述明监查日期、时间、监查员姓名、监查的发现等，并存档。19进度调节根据不同医院进度，经相应临床中心同意后适当进行病例调节。20中期或年度临床进度报告根据临床进度情况，向SFDA报告中期或年度临床进度情况。临床试验总结阶段21回收CRF表 监查员回收CRF表，并做专业和技术审核。22揭盲 监查员会同主要研究者、统计专家共同揭盲，并填写揭盲记录。23编写统计方案书监查员独立或与主要研究者一起共同编写总结大纲；同统计专家一起，根据

7、临床试验目的和总结大纲，编写并审核临床统计方案书。24数据录入统计专家建立数据库；监查员对数据库进行审核；监查员协同并监查数据录入。25编写程序 统计专家编写统计运算程序。26统计运行统计程序，监查员应对出现的问题协同解决；对统计检验发现的问题，监查员负责协同研究者进行答疑。27统计报告统计专家出具统计报告；监查员负责对统计报告进行审核并提出具体意见。28起草临床大总结和分总结临床监查员独立或协同研究者起草临床总结；临床总结最终由研究者审核并确定。29临床总结会根据需要，临床监查员召集各临床中心研究者和统计专家召开临床总结会；会议程序同临床协调会。30申报资料完成监查员负责将最终定稿临床总结打

8、印校对完毕并装订成上报材料；将定稿临床总结送交注册组。临床试验结束后31向伦理委员会报告向伦理委员会报告试验结束函；试验结束后的严重不良事件报告32试验用药销毁详细记录试验用药品的回收、存放；详细记录临床药品的销毁方法与经过。33文件存档临床试验中所有文件均需按GCP要求存档，并指定专人负责。其他工作34制定标准操作规程SOP 临床研究每项工作均需制定标准而详细的书面规程，即标准操作规程SOP。35文档管理严格遵循“Norecord，Noaction“之原那么，对临床中涉与的每项工作均进行文件归档管理，并按照GCP要求存放。36学习与培训药政法规学习；专业学习医学、药学、统计学等；每个工程临床

9、启动前，临床监查员均需要对该工程涉与的各项知识进行学习、培训，并经过考核合格前方可进行该工程的临床监查。2、盐酸阿比朵尔Arbidol制剂已在我国上市，请查询阿比朵尔在抗病毒方面的药效学和临床试验的相关资料主要为英文资料。Sensitivity of various influenza virus strains to arbidol. Influence of arbidol combination with different antiviral drugs on reproduction of influenza virus ALeneva IA, Fediakina IT, Gusko

10、va TA, Glushkov RG.AIM: To study antiviral activity of arbidol in relation to various antigenic subtypes of influenza virus isolated from humans; efficacy of arbidol action in combination with adamantanic antiviral drugs, ribavirin and ribamidil on reproduction of influenza virus A （IVA） in cell cul

11、ture. MATERIAL AND METHODS: The activity of the drugs against viral reproduction was assessed by inhibition of viral antigens expression detected in virus-infected cells using enzyme immunoassay （EIA）. RESULTS: Arbidol is just as good as adamantanic drugs, neuraminidase inhibitors, ribavirin and rib

12、amidil by its inhibiting activity in relation to influenza viruses A and B. Arbidol inhibits reproduction of human IVA antigenic strains H1N1, H2N2, H3N2 and remantadin-sensitive and remantadin-resistant strains of influenza virus. Arbidol inhibits reproduction of pathogenic for humans strains of av

13、ian influenza virus H5N1 and H9N2, strains H6N1 and H9N2 having internal genes common with H5N1 and H9N2. The inhibiting activity of arbidolin on cell culture viral reproduction enhanced if arbidol was used in combination with amantadine, remantadin, ribavirin and ribamidil. CONCLUSION: Arbidol has

14、a wide spectrum antiviral activity and inhibits reproduction of various antigenic subtypes and remantadin-resistent human IVA, avian viruses H5N1 and H9N2, influenza viruses B and C.Arbidol used in the prophylaxis of acute respiratory viral infections and their complications in servicemenShuster AM,

15、 Shumilov VI, Shevtsov VA, Marin GG, Kozlov VN.The prophylactic action of arbidol to prevent the acute respiratory viral infections and their complications （extra-hospital pneumonia） was studied under conditions of two military collectives during winter and summer time. The data obtained confirm the

16、 prophylactic activity of the drug in respect of acute respiratory viral infections. Regardless of the degree of disease epidemic rise among the servicemen who didnt take arbidol the minimal threshold of influenza and other acute respiratory viral infections incidence （10-15%） remained in the experi

17、mental group. The incidence of pneumonia decreased. It was connected with decrease in viral-and-bacterial pneumonia. The number of patients with bacterial （generally pneumococcal） pneumonia didnt change.Efficacy and safety of arbidol in treatment of naturally acquired influenzaWang MZ, Cai BQ, Li LY

18、, Lin JT, Su N, Yu HX, Gao H, Zhao JZ, Liu L.Department of Respiratory Disease, PUMC Hospital, CAMS and PUMC, Beijing 100730, China. OBJECTIVE: To evaluate the efficacy and safety of Arbidol in the treatment of naturally acquired influenza. METHODS: A randomized, double-blinded, placebo controlled t

19、rial was conducted. Subjects were enrolled. The inclusion criteria included: aged 18 to 65 years, presented within 36 hours of onset of influenza symptoms; and had documented temperature of 37.8 degrees C or higher during an influenza outbreak in the community. Individuals were randomly divided Arbi

20、dol group （200 mg three times daily for 5 days） or placebo group.RESULTS: Totally 232 individuals were recruited and received medication and follow-up. All of them were qualified to be analyzed for safety as intent-to-treat population （ITT） （113 Arbidol, 109 placebo）. Twenty-two （9.48%） were during

21、follow-up or refused to continue the trial, and 210 completed as scheduled and identified as PP population （102 Arbidol, 108 placebo）. Totally 125 individuals were identified as influenza-infected through laboratory test, which was defined as PPi population （59 Arbidol, 66 placebo）. In PPi populatio

22、n, the cumulative alleviation proportion of Arbidol group was significantly higher than that of placebo group. The median duration of illness was 72.0 hours （95% confident interval （CI） 66.00-78.00 hours） in Arbidol group and 96.0 hours （95% CI 87.46-104.54 hours） in placebo group. The median area u

23、nder the curve （AUC） of decreased total score were significantly higher in Arbidol group than in placebo group, which were 780.00 and 684.00 score-hours respectively. For PP population, similar results were seen. Adverse events reported were similar in Arbidol group and in placebo group. The main ad

24、verse events were gastrointestinal symptoms and increased transaminase.CONCLUSION: Arbidol was effective and well tolerated in the treatment of early naturally acquired influenza.Clinical TrialArbidol hydrochloride Pharmacodynamic study of anti-influenza virus infectionSun Yan-chi, ZHANG Shu-qin LIU

25、 Zhi-yi Liu Jianwei JinyuqinStudy about pharmacodynamics of arbidol hydrochloride on Influenza virus infectionAbstract Objective : To investigate the effects of the anti-influenza virus Arbidol role. Methods vivo, in vitro model of influenza virus. Application for a certain concentration of hydrochl

26、oric acid in vitro Arbidol role in the influenza A virus subtype H1N1 infection of host cells. To investigate the use of CPE and the cell viability was measured by MTT assay; hydrochloric acid in vivo application for the treatment of influenza virus infection in mice Arbidol model Index changes in t

27、he lung. Arbidol hydrochloride results in vivo, In vitro anti-influenza viruses have the same effect. Conclusion Arbidol hydrochloride is a good anti-virus drugs. Keywords : Arbidol hydrochloride; The influenza virus; Pharmacodynamics Key words : School OfficAuthor : Jinyuqin （1979-）, female, master

28、s degree students, research direction : virology; Sun - （1958-） male, masters, professors and research directions : virology, communications authors Tel:, Fax : , E-mail : The goal : Jinyuqin （Regenerative Medicine Institute of Science Laboratory at Jilin University, Jilin, Changchun 130021） Sun - （

29、Regenerative Medicine Institute of Science Laboratory at Jilin University, Jilin, Changchun 130021） Shuqin （Regenerative Medicine Institute of Science Laboratory at Jilin University, Jilin, Changchun 130021） Shu-qin LIU Zhi-yi （Regenerative Medicine Institute of Science Laboratory at Jilin University, Jilin, Changchun 130021） Liu Jianwei （Regenerative Medicine Institute of Science Laboratory at Jilin University, Jilin, Changchun 130021） Yan Qi （Changchun College of Respiratory Medicine, Jilin, Changchun 130021）References :1 Zhong Bin, Wang Sheng, , Sun et al. influenza in Thail