监查员职责.doc

responsibilities 工作职责part i: project team leadership and management （if assigned）第一部分：项目团队领导和管理(1) planningl planning of project activities and study timelines based on project goal and sponsors expectation.1、 计划 项目活动的规划和研究时间表基于项目目标和赞助商的期望。(2) implementation 实施l organize and lead meeting/teleconferences for study activities implementation (e.g. investigator调查员 meeting, project review meeting etc), monitoring the progress of each cra responsible sites, and assessing overall status of the project.2、 实施 组织、 引导会议/电视电话会议进行研究活动实施 （例如调查员会议、 项目审核会议等）、 监查每个（临床监查员负责任的）站点的进展和评估项目的总体状态。l develop the project management plan, monitoring plan etc as required for the study.根据所需的研究制定项目管理计划，监测计划等。l develop study specific tools/forms, study templates as required for the study.根据所需的研究制定研究特定的设备和表格，研究模板等。l develop and manage project budget.做好预算。l order and ensure all clinical supplies (including drug and non-drug) are adequate for all sites throughout the study period.在整个研究过程中，有计划的为每个医院站点确保所有（包括药物和非药物）的临床供应充是充足的。l ensure all team members have timely access to appropriate systems and tools, if applicable (e.g.ivrs, ecrf etc)确保所有团队成员都能及时获得相应的系统和工具，如果适用l organize and conduct site feasibility visits according to guidelines and make recommendation for final approval.组织并进行指导访问站点的可行性，为最终批准提出建议l coordinate the application of specimen export permit, if applicable.协调标药品出口许可证的应用，如果可以l maintain and manage all project trial master files throughout the study period and coordinate the long term archiving（存档） and handover to sponsor at the end of the study.维护和管理整个研究过程中的所有项目试验主要文件，协调长期存档并且在研究结束后将文件交给研究者。l conduct the co-visit at site with cra according to tigermed sop根据泰格标准操作规程在站点同临床研究员进行访视(3) tracking 跟进l track study progress and ensure project is conducted according to the plan.跟进研究进展，确保项目按照计划进行(4) communication 交流l communicate to monitors new study information, study timelines and goals, study requirements.与监查员交流新的研究信息，研究时间表和目标以及研究要求。l responsible for raising overall project specific issues to management (e.g. project director项目总监, senior management高层管理者).负责向管理者提高整体项目特定问题。l submit（提交） the weekly project report to management (e.g. project director, senior management).每周向管理者提交项目计划报告。l communicate to sponsor study status and key issues与研究者交流研究情况和关键问题。l generate monthly project status report to sponsor.每月向研究者提供项目状态报告。part ii: study implementation第二部分： 研究实行(1) monitoringl monitoring 监测n perform pre-study visit to ensure the site has adequate resources for the study.完成研究前的访视，确保此站点有充足的研究资源。n ensure principal investigator/study staff complies with（符合） safety reporting requirements, as defined in protocol, sop and ich-gcp.按照协议、sop、ich-gcp中的描述，确保主要调查/研究人员符合安全报告的要求。n track study recruitment to ensure recruitment（招募者） target is achieved in all studies.在所有研究中为确保实现受试者（志愿者）的目标，要时刻跟进研究招募。n conduct monitoring visit according to sdv plan and sop; address issues with sites and complete monitoring visit report in a timely manner coordinating根据sdv 计划和 sop，进行监测访视，要及时协调好与站点解决问题和完成监测访视报告两方面工作。n ensure timely coordination of study materials (drug, non-drug, equipments, crfs) to the site for start-up and throughout the study从站点启动到整个研究里，要确保能及时协调的研究材料（药物的 非药物的设备，病例报告表等等）n assemble 收集site specific ec submission dossier, and ensure submission to ec.training 培训n provide ongoing training to site staff with regards to ich-gcp, study protocol（方案） and requirements.提供持续的培训，关于ich-gcp的学习，还有研究方案和要求。n conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.进行站点启动，确保医院对研究方案和要求有个透彻理解。l documentation 记录n collect essential documents at study start-up, during and at study close-down. maintain and update these documents in investigator files, trial master files.在研究启动时，研究中，以及结束时收集必要的文件。并在调查员文档和试验主文档中维护和更新这些文件。n prepare/pack for archiving存档 at the end of the study.在研究结尾时，准备（/打包）存档。(2) drug safety药物安全l ensure safety information is disseminated（发放） to all sites according sop and applicable regulations.根据sop和适用的条例，确保所有安全资料发放给所有站点医院。l report sae promptly according to sops and applicable regulations.及时报告sae，根据sop和适用的条例。(3) finance and administration 资金和管理（财政和行政）finalize budget and obtain signed contract from site, prior之前 to site initiation visit.在站点开始访视之前，从获得签署的合同，做出最后预算。l ensure study payment schedule is executed执行 and retain保留 relevant documents/receipts.确保执行研究付款计划和保留相关的文档/收据。(4) study tools and system 研究工具和系统l update and maintain study tools/systems in a timely manner.（用的方式）为什么要从事这个行业？最初的想法是不喜欢天天呆在实验室的生活，希望从事与人接触的工作，喜欢更有挑战的工作。现在希望临床试验能通过我们的努力更规范、能与国际真正接轨。让大家能够看到真正的试验结果，最终结果就是为了得到真正的好药。一次典型的监查拜访需要做的工作：1、核对数据、请研究者修改再回收crf 占工作量50%2、协助研究者解决dqf（数据质疑） 5%3、检查原始文件的记录保存是否符合要求 20%4、病人病历、化验单，查看知情同意书，查看生物样本的采集运输记录（也是原始文件）是否符合要求，检查和更新研究文件夹、添加更新的文件 10%5、清点药品，查看发药记录、查看药品保管记录（温度等，这些也属于原始文件） 15%6、定期回收药品7、协助研究者完成sae报告（如果适用。注意sae的报告是研究者的责任，同时sae报告上要用受试者姓名缩写或者只是入选编号。最多头一次到医院协助，不主张每次都协助，会导致研