07Session 6 理解临床试验的风险管理understanding the risk managment of clinical trials MM CN 医疗器械临床试验管理与统计分析培训班讲义.ppt

Step 1 第一步 Identify quality risks (perform risk assessment) 识别质量风险 （进行风险评估） Step 2 第二步 Conduct Study 进行研究 Step 3 第三步 Using risk metrics, monitor performance 运用风险指标监督绩效 Step 4 第四步 Perform RCA & CAPAs 进行RCA和CAPA Risk Management Plan 风险管理计划 * Up-front planning requires initially more time and cost 事前计划最初要求更多的时间和费用 Lack of fundamental understanding of the nature of Risk Management 缺乏对风险管理属性的基本了解 Ongoing review of processes might require additional resources 不间断的程序审阅也许要求额外的资源 Appears to add complexity 似乎增加复杂性 Cultural change in how studies are currently being conducted 文化在如何进行当前的研究中发生改变 * * 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 助理顾问 Global Medical Qualtiy, Eli Lilly & Company, USA 全球医药质量部，美国礼来制药公司 Information/Data sufficient to support the decision making process throughout the clinical development and post-market approval 足以支持临床研发全过程和上市批准后决策的信息/数据 Collecting data, generating information, enabling decision making by: 收集数据，产生信息，使得下列人员可以做出决策： Sponsors 申办者 Ethics Committees 伦理委员会 Regulators 监管者 Investigators 研究者 Healthcare Professionals 卫生保健专业人员 Study Subjects 研究受试者 * IDENTIFYING THE PROBLEMS 鉴别问题 Enforcement actions with clear messages on deficiencies 缺陷清晰信息的强制行动 Lack of confidence in data due to poor quality 由于质量不佳缺乏对数据的信心 Insufficient monitoring of investigation sites 不充分的研究机构监查 Questioning if sponsors have CROs in control 疑虑申办者是否有CRO在管理 Corrections failed to be systemic or effective 纠正不成功系统或无效 DISCUSSIONS ABOUT THE SOLUTIONS 解决方案讨论 Discussions on quality and how to improve the deficiencies 讨论质量和如何改善缺陷 Build quality into the program 构建质量于程序中 Apply risk management to target resources appropriately 应用适当的风险管理到目标资源中 Define controls to prevent errors 明确监控来预防错误 Identify problems and intervene before issues become endemic 鉴别问题并在变得严重前解决它 * Quality Management Systems (QMS –