仁濟(jì)醫(yī)院臨床研究中心(以下簡稱“中心”)以臨床需求為導(dǎo)向,,以服務(wù)健康為導(dǎo)向,,構(gòu)筑標(biāo)準(zhǔn)化,、精準(zhǔn)化,、多能化的臨床研究運維體系,提供研究方案設(shè)計與協(xié)調(diào),、研究跟進(jìn)與監(jiān)管,、數(shù)據(jù)管理與分析,、論文撰寫等全鏈條支持服務(wù),,滿足研究者對臨床研究全生命周期的一站式服務(wù)需求。
中心成立以來,,基于CDISC(Clinical Data Interchange Standards Consortium)ODM(Operational Data Model)標(biāo)準(zhǔn)開發(fā)了臨床研究與科研共享大數(shù)據(jù)平臺,,且構(gòu)建了兼容臨床研究服務(wù)與監(jiān)管的CRMS(Clinical Research Management System)系統(tǒng)正式上線,為開展高質(zhì)量臨床循證研究及轉(zhuǎn)化研究提供信息化支撐平臺。同時,,圍繞影響人民健康的重大疾病和突出問題,,中心建成多個完成數(shù)據(jù)治理的專病隊列,其中包括十萬級大型隊列,,形成集合的全量數(shù)據(jù)庫,,為臨床研究提供堅實數(shù)據(jù)基礎(chǔ)。
中心面向多院區(qū)提供全覆蓋,、多層次的臨床研究培訓(xùn),,包括針對PI、研究骨干和初學(xué)者的分層次課程和細(xì)化需求為導(dǎo)向的專題培訓(xùn)(“統(tǒng)計師+臨床醫(yī)師”共同解讀臨研文獻(xiàn)等實戰(zhàn)課程),,致力于解決醫(yī)生在臨床研究實踐中的瓶頸與困局等熱點問題和重要環(huán)節(jié),;CRC/CRN培訓(xùn)課程,培養(yǎng)一支高效,、專業(yè),、穩(wěn)定的臨床研究協(xié)調(diào)員及研究護(hù)士隊伍。
作為支撐醫(yī)學(xué)轉(zhuǎn)化服務(wù)平臺,,中心推動醫(yī)企深度融合,,探索醫(yī)企聯(lián)動模式,助力開發(fā)一批具有自主知識產(chǎn)權(quán)的新設(shè)備,、新技術(shù),、新藥,推動上下游產(chǎn)業(yè)鏈共同高質(zhì)量發(fā)展,,促進(jìn)醫(yī)學(xué)進(jìn)步,。
未來,中心將緊跟醫(yī)院發(fā)展規(guī)劃,,服務(wù)于醫(yī)院與學(xué)科發(fā)展的創(chuàng)新戰(zhàn)略,,進(jìn)一步提高醫(yī)院臨床研究的水平和質(zhì)量,促進(jìn)臨床研究邁上新臺階,。
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.