session2临床试验质量依从性的基础：qaqc要素和质量管理体系医疗器械临床试验管理与统计分析培训班讲义

Session 2：Fundamentals of Quality Compliance of Clinical trials: QC/QA Elements and QMS,Institute of Executive Development State Food and Drug Administration of China Training Program of Clinical Trial Management in Medical Device Development Nanjing, China September 28-29, 2012 Mary Ann Morris Associate Consultant Global Medical Quality，Eli Lilly & Company, United States,第二部分：临床试验质量依从性的基础： QA/QC要素和质量管理体系,The goal of quality in clinical research is to ensure the collection of data in integrity in an ethical manner that protects and safeguards subjects throughout the life of a clinical trial Data integrity is the assurance of the trustworthiness and reliability of data,Why Qulaity? 为什么要质量?,2,临床研究中质量的目的是为了 确保数据采集的完整性 伦理要求 保护和保障受试者 贯穿于临床试验的生命 周期 中 数据完整性是保障试验数据的可信度和可靠度,There is no regulation that says a company must have a Quality Management System, or QMS. However 没有法规说一个公司必须有质量管理体系（QMS)。然而 Industry best practice is for companies to have a quality management system appropriate to their size, the products they produce, and their company culture. 业界最佳实践就是需要公司针对他们的规模、生产的产品和公司文化建立质量管理体系。,How Do We Ensure Quality in Clinical Research? 如何确保临床研究中的质量?,3,A set of policies, processes and procedures required for planning and executionin the core business area of an organization. QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance. as defined by ISO 9001:2008. 一套计划和运营所要求的政策、流程和规程在一家组织机构的核心商务领域中。QMS整合组织内部的各个流程，并可提供项目运营的流程途径。QMS可使组织机构鉴别、权衡、监控和改善最终可导致商务绩效得以提高的各种核心商务流程成为可能 。 载自ISO 9001:2008,One Definition of a Quality System 质量体系的定义,4,The most widely accepted model for a QMS is ICH GCP E6 最广为接受的QMS模式源于ICH GCP E6 E6 does not have a section on clinical quality systems but E6 并没有临床质量体系，但是 Section 2.13 states:第2.13 部分指出: Systems with procedures that assure the quality of every aspect of the trial should be implemented. 确保试验每一个方面质量的规程体系应当被实施。,QMS According to ICH GCP E6 ICH GCP E6定义的QMS,5,Management Support/Involvement Trained/Qualified Personnel Quality Control (QC) Quality Assurance (QA) Continual Improvement,Quality Components of a Successful QMS 成功QMS的质量内涵,6,管理层的支持和介入 经过培训的/合格的人员 质量控制 (QC) 质量保障 (QA) 持续改善,Management should establish a quality system that includes policies, procedures and processes to meet the regulatory, quality control, and quality assurance expectations 管理层应当建立包括政策、规程和流程在内的质量体系，以满足监管、质量控制和质量保障的期许 As part of the QMS, management should also establish a process to capture, quantify and analyze performance. If properly done, it will allow for continual improvement. 作为QMS的部分, 管理层也应当建立能采集、量化和分析绩效的程序。如果正确运用，它可以使得持续改善成为可能。,Management Support/Involvement 管理层的支持/介入,7,Management responsibilities: define the scope of the QMS supply the resources resources money establish and maintain the system make key decisions hold people accountable define clear roles and responsibilities,Management Support/Involvement 管理层的支持和介入,8,管理层的职责: 规定QMS的范畴 提供资源 物力 财力 建立和维护体系 作出主要决策 明确人员归属 规范清晰的角色和责任,Management should ensure procedures in the QMS are to ensure people know what to do. 管理层应当确保QMS中的规程人人皆知如何去做。 Sometimes organizations generate procedures to pass regulatory inspections or third-party audits. 有时组织机构产生的规程能经得起监管视察或第三方稽查。 The real purpose behind having a procedure is so employees know how to do a task consistently time after time. 规程背后的真实目的是要雇员知道如何时刻恒定地完成所担负的职责。 These procedures should clearly define roles and responsibilities so all know who is doing what and when. 这些规程应当清楚地规定角色和责任，以至于所有人员都知道谁在做什么和何时要做。,Management Support/Involvement 管理层的支持和介入,9,Qualifications The quality management system should define what the qualifications or requirements of the person conducting a specific task should be. For example, if a task should be done by a nurse, there should be documentation typically found in a job description that a nurse with X number of years of experience should fill the role for this procedure. Training The system should explain how training will be done.,Trained/Qualified Personnel 经过培训的/合格的人员,10,资质 质量管理体系应当明确承担某项特殊任务的人员应该具有什么样的资质和要求。 例如，如果一项任务应当有护士来做的化，通常应当在岗位责任说明中表明具有X年经验的护士应当担任这个规程中的角色。 培训 体系应当解释如何进行培训。,Per ICH GCP E6, 5.1.1: The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). 根据ICH GCP E6, 5.1.1: 申办者负责用书面SOP的形式实施和维护质量保障和质量控制体系，以便确保试验的进行、数据的产生，文档记录和报告都符合试验方案、GCP和相应的监管要求。,Quality Control and Quality Assurance 质量控制和质量保障,11,QC ensures accountability exists for quality QC 确保责任制存在于质量之中 QA ensures that appropriate quality controls have occurred QA 确保有相应的质量监控,Quality Control vs. Quality Assurance 质量控制与质量保障,12,The operational t