Conference Session Description
会前培训和研讨专题简介 | Session Description of Pre-Conference Workshop
上午并行专题
Morning Parallel Sessions
专题A：还在用Excel做dashboard吗？专家教你如何轻松实现临床数据管理可视化
Track A: Expert teach you how to realize visualization in Clinical Data Management
在临床数据管理中，我们需要收集、利用、分析、可视化数据，以进行研究健康状况检查和日常工作管理。人们习惯于使用Excel来收集和显示我们需要支持业务的各种数据（例如，质量，绩效指标等）。但是，它也有许多局限性，随着技术的发展，我们可以以智能的方式管理和可视化所需的数据。在本次研讨会中，我们邀请了绩效指标和仪表盘方面的专家向您展示如何在临床数据管理领域实现可视化。
There are many areas we need to collect, utilize, analyze, visualize data for study health status check and daily work management in Clinical Data Management. People are so used in using Excel to collect and show all sorts of data we need to support business (e.g., quality, performance metrics, etc.). However, it has many limitations and with the evolvement in technologies, we can manage and visualize the data we need in a smart way. This workshop, we invited experts in performance metrics and dashboards to show you how to realize visualization in Clinical Data Management area.
专题B：临床数据管理的项目管理技能
Track B: Project Management Skills on Data Management Works
是否想了解全球数据管理变革时期中，对临床数据管理的项目管理的影响和要求？面对革新，如何与时俱进用新的科技，新的视角，对临床数据管理工作进行高效管理？基于大家日常工作中遇到的挑战，面对的变革挑战，本专题邀请行业大咖们为大家讲解临床数据管理的变革焦点，新科技引领临床数据管理的项目管理领域中新方法学。同时第一次在工作坊中引进实践中的真实案例，进行分享和结合技能进行练习，帮助行业伙伴们针对性体会技巧和技能，解决DM项目管理实际工作中的难点。
Do you want to acknowledge the impact and requirements of project management for clinical data management in the era of data management globally transformation? In the face of innovation, how to advance with the times and utilize new technologies & perspective to efficiently manage clinical data management works? In view of the challenges, you encounter during your daily work and transformation challenges, SCDM Sub-Committee “China Project Management” meticulously prepare the content of this workshop. We invited industry experts to guide focal points of clinical data management evolution, and new technology driving new methodology in the field of DM Project Management. Meanwhile, this is the first time to adopt real cases into the workshop. You will learn and practice on DM PM solutions in Case Study session.
下午并行专题
Afternoon Parallel Sessions
专题C：CDISC临床数据采集标准（CDASH）介绍与建库自动化考量
Track C: Introduction of CDASH and its application in automated database setup
CDASH建立了一套标准方法来收集试验数据，适用于不同的临床研究、不同的申办方，使用广泛，并且得到了各国监管部门的推荐。本课程中，讲师将从CDASH模型，IG，域，字段，元数据以及最佳操作建议等角度进行展开，并对CDASH与SDTM的异同做出归纳。课程配备随堂练习，学员将应用所学知识现场制作CRF，确保学以致用。
CDASH establishes a standard way to collect data consistently across studies and sponsors, it is widely used and has been recommended by many regulatory authorities. In this course, the lecturer will elaborate CDASH model, CDASH IG, domains, fields, metadata and best practice recommendations, similarities, and differences between CDASH and SDTM will also be covered. Exercises are available in the course and students will apply their knowledge to create CRF and ensure they have a practice of what is learnt.
专题D：外部数据的核查
Track D: Data Validation for External Data
随着数字技术的发展，特别是在疫情期间，更多公司正在投资引进先进技术，以在EDC系统之外直接从患者那里收集数据。本专题将侧重于外部数据的验证，并提供深入的案例研究和知识共享。
With the evolving of Digital Technology especially, during the pandemic, more companies are investing in bringing in advanced technologies to collect data outside of EDC system and directly from the patients. This workshop will focus on the validation of the external data and provide in-depth case studies and knowledge sharing.
*以上四个会前培训研讨专题各为期半天，参会人员可根据四种不同组合（专题A+C，A+D, B+C, B+D）注册参加；
大会专题简介
Session Description
专题1：法规要求、标准及递交
Session 1: Regulatory Requirements and standards, eSubmission
ICH GCP R3即将被颁布，ICH官网上已经将原则草案加以公布，其中提到受试者的隐私如何按照法规要求被保护，以及如何确保临床试验结果的可信性等。2022年8月CDE关于公开征求《药物临床试验盲法指导原则》意见，其中涉及到盲态数据审核等。所以本专题将就这些法规要求从临床数据管理应用实践等角度加以分享与讨论。
ICH GCP R3 will be released soon. The draft principles have been published on the ICH official website, which mentions how the information privacy of the subjects is protected in accordance with the regulatory requirements, and how to ensure the reliability of the clinical trial results. In August 2022, CDE publicly solicited opinions on the Guideline of Blinded Methods in Drug Clinical Trials, which involves blinded data review, etc. Therefore, this session will share and discuss these regulatory requirements in clinical data management practice.
专题2：eCOA的设计及应用 – 以患者为中心的DCT试验
Session 2：eCOA Design and Application – patient centric DCT
目前，电子临床结果评估（eCOA）已成为临床试验中收集受试者数据的一种主要方法，它不仅能高效采集高质量临床数据，同时也满足法规的严格要求。与此同时，随着近些年Decentralized Clinical Trial (DCT)试验的不断推广，eCOA逐渐显示其优势，同时eCOA结合远程医疗平台，可最大化提升DCT体检。此会议环节主要讨论在DCT试验中，eCOA应如何合理设计和应用，以及数据管理中的特殊性，和其中数据安全及监管法规要求，尤其在global DCT时，可能还需要额外考虑的问题。
Electronic clinical outcome assessment (eCOA) has become one of the primary method for collecting subject data in clinical trials, not only because it can efficiently collect high-quality clinical data, but also can meet stringent regulatory requirements. Nowadays, with the continuous promotion of Decentralized Clinical Trial (DCT) trials in recent years, eCOA has gradually shown its advantages, especially once eCOA combined with telehealth platforms, which can maximize DCT experiences. This session will mainly discuss how eCOA should be properly designed and applied in DCT trials, as well as the specialties in data management, and the data security and regulatory requirements, especially in global DCT, which may need additional consideration.
大会专题简介
Session Description
专题3：GCDMP与应用分享
Session 3：GCDMP and Practice Sharing
临床数据质量管理规范（GCDMP）是临床数据管理人员进行高质量临床试验数据管理工作的指导，积聚了数据管理的全流程业务内容和实践经验，是被行业认可的临床数据管理专业指导工具。随着临床数据管理向临床数据科学演进，新技术和数字化在临床试验中的应用和深化，GCDMP也在持续更新内容，与时俱进。本专题将邀请GCDMP主编及业内专家介绍GCDMP及其内容更新进展，分享如何使用这一工具更好的开展临床数据管理工作。
GCDMP provides assistance to data managers in their implementation of high-quality data management processes and serves as an industry recognized tool offering professional guidance on clinical data management. With the evolution of clinical data management to clinical data science, and with the application of new technologies and digitalization in clinical trials, GCDMP is constantly updating its content to stay up to date. In this session, GCDMP chief editor and industry experts will be invited to introduce GCDMP and its content update progress and share how to use this tool to better implement clinical data management.
专题4：临床数据管理中基于风险的质量管理措施（RBQM）
Session 4：Risk Based Quality Management Approach in Clinical Data Management
ICH、FDA和NMPA均发布了基于风险的项目管理指导原则。新冠疫情也加速了RBQM在临床开发中的实施需求。本专题将讨论临床数据管理如何采用RBQM来识别和控制风险，同时关注对质量至关重要的数据和流程。主题将包括设计质量方法、集中监控、质量公差限值（QTL）、质量关键因素（CtQ）等。
ICH, FDA and NMPA all published the guidelines on risk-based trial management approaches. COVID pandemic also accelerated the needs of implementation of RBQM in clinical development. This panel session will discuss how Clinical Data Management can adopt the RBQM to identify and control risk while focusing on the critical to quality data and processes. The topics will include Quality by Design approach, Centralized Monitoring, Quality Tolerance Limits (QTLs), Critical to Quality (CtQ) factors and etc.
专题5：技术创新提高数据管理的效率和质量
Session 5: Technological Innovation Enhancing Efficiency & Quality of Data Management
近年来，随着临床试验规模的不断扩大和数据量的急剧增长，临床试验过程中的数据管理工作已发生了很大的变化。在数据管理的过程中，技术创新提供了有效的解决方案。越来越多的新技术和创新工具被引入，用以优化临床试验数据管理流程，提高数据处理和质量控制的效率及准确性。这些技术的应用可以更好地推动临床试验的信息化发展，支持新药研发和临床实践，加快新药研发和上市进程。该专题旨在研究和探讨现有技术创新在临床试验数据管理中的应用，以及如何进一步提高数据管理的效率和质量，以满足临床试验数据管理的需求，推动医学研究和创新。
In recent years, the scale and volume of clinical trials have rapidly increased, resulting in significant changes in data management practices. To optimize the clinical trial data management process and improve efficiency & accuracy, new technologies and innovative tools have been introduced. These technologies can promote the development of clinical trial informationization, support drug development and clinical practice, and accelerate the research and approval process. This topic aims to explore the application of existing technological innovation in clinical trial data management and to further improve the efficiency & quality to support medical research and innovation.
组委会 | Program Committee
张薇 | Wei Zhang
[SCDM China Steering Committee Chair; Head of Data Management, GSK Shanghai R&D]
颜崇超 | Charles Yan
[SCDM China Steering Committee Vice Chair; Chief Data Officer, Clinical Data Science Center, Shanghai Shengdi Medicine Co., Ltd.]
张玥 | Carrie Zhang
[SCDM China Steering Committee Member; Vice President, Data Science Center, Global Product Development, Shanghai Henlius Biotech, Inc.]
邓亚中 | Yazhong Deng
[SCDM China Steering Committee Member; General Manager, Beijing Trust Medical Consulting Co., Ltd.]
田正隆 | Zhenglong Tian
[SCDM China Steering Committee Member; Vice President, Chief Data Officer, Clinical Research Center，GoBroad Healthcare Group]
黎婉珊 | Joyce Lai
[SCDM China Steering Committee Member; Senior Regional Director, Clinical Data Management, Global Data Management & Standards, MSD R&D (China) Co., Ltd.]
孙华龙 | Hualong Sun
[SCDM China Steering Committee Member; Chief Operational Officer, Clinical Service Center; General Manager of Meta Data Technology]
张蕴 | Sally Zhang
[SCDM China Steering Committee Member; Sr Director, Head of Great China GDM, IQVIA]
倪丽萍 | Annie Ni
[SCDM China Steering Committee Member; Director, Program Lead, Clinical Data Acquisition, China Data Monitoring & Management, Pfizer (China) Research and Development Co., Ltd.]