仁济医院临床研究中心(以下简称“中心”)以临床需求为导向,以服务健康为导向,构筑标准化、精准化、多能化的临床研究运维体系,提供研究方案设计与协调、研究跟进与监管、数据管理与分析、论文撰写等全链条支持服务,满足研究者对临床研究全生命周期的一站式服务需求。
中心成立以来,基于CDISC(Clinical Data Interchange Standards Consortium)ODM(Operational Data Model)标准开发了临床研究与科研共享大数据平台,且构建了兼容临床研究服务与监管的CRMS(Clinical Research Management System)系统正式上线,为开展高质量临床循证研究及转化研究提供信息化支撑平台。同时,围绕影响人民健康的重大疾病和突出问题,中心建成多个完成数据治理的专病队列,其中包括十万级大型队列,形成集合的全量数据库,为临床研究提供坚实数据基础。
中心面向多院区提供全覆盖、多层次的临床研究培训,包括针对PI、研究骨干和初学者的分层次课程和细化需求为导向的专题培训(“统计师+临床医师”共同解读临研文献等实战课程),致力于解决医生在临床研究实践中的瓶颈与困局等热点问题和重要环节;CRC/CRN培训课程,培养一支高效、专业、稳定的临床研究协调员及研究护士队伍。
作为支撑医学转化服务平台,中心推动医企深度融合,探索医企联动模式,助力开发一批具有自主知识产权的新设备、新技术、新药,推动上下游产业链共同高质量发展,促进医学进步。
未来,中心将紧跟医院发展规划,服务于医院与学科发展的创新战略,进一步提高医院临床研究的水平和质量,促进临床研究迈上新台阶。
The Center for Clinical Investigation of Renji Hospital (hereinafter referred to as the "CCI") is dedicated to clinical research needs and health services. The Center develops a standardized , precise, and multifunctional system to run and manage clinical research by , offering a complete range of support services. The CCI upholds the teams of investigators by delivering expertise in all the phases of clinical research, proving resources for one stop services, such as research protocol design and coordination, research follow-up and supervision, data management and analysis, and paper writing.
Since its foundation , the CCI has developed a big data sharing platform for clinical research based on the Clinical Data Interchange Standards Consortium (CDISC) () Operational Data Model (ODM), and has built a Clinical Research Management System (CRMS). Since the system became operational , it was compatible with clinical research services and supervision, coming to be an information support platform for high-quality clinical evidence-based research and translational research. Concurrently, the CCI has built several disease-specific cohorts with complete data governance, including the major diseases and important threats affecting people's health. With its 100,000-level large cohorts, CCI offers a full-volume database collection that ensures a solid data foundation for clinical research.
The CCI offers a full-coverage and multi-level clinical research training for branches, including hierarchical courses for PI, research cadres and beginners, and demand-driven training (practical courses such as "statisticians + clinicians" interpreting clinical research literature), that are meant to address bottlenecks and doctors ‘dilemmas in clinical research practice. The center provides also CRC/CRN training courses to promote an efficient, professional and stable team of clinical research coordinators and research nurses.
As a service platform to support medical translation, the CCI promotes the deep integration of medical enterprises by exploring their possible collaborations, , it supports the development of new devices, new technologies and new drugs with independent intellectual property rights. Finally, the CCI supports the upstream and downstream industrial chains’ high-quality development and promotes medical progress.
In the future, the CCI will follow the hospital’s development plan, will serve its innovation strategy and discipline reinforcement , and will boost clinical research to a new level.