Clinical Research Management
Management practice of Investigator-Initiated Trials in the new period
Zhu Qi, Li Mengshi, Jin Jing, Gao Jinyuan, Xue Qian
Published 2023-08-21
Cite as Chin J Med Sci Res Manage, 2023, 36(4): 308-311. DOI: 10.3760/cma.j.cn113565-20230207-00023
Abstract
ObjectiveIn the context of China′s increasing standardized management requirements of clinical research, this article aims to explore the management methods of investigator-initiated trials in the new period, to provide possible reference for other medical institutions dedicated to clinical research.
MethodsAccording to the requirements set forth by the＂Administrative Measures for Investigator-Initiated Trials in Medical and Health Institutions (Trial)", combined with the hospital management practice, experiences regarding the research management system construction and implementation, management system construction and its implementation effects are summarized and analyzed.
ResultsBy exploring and summarizing the connotation of high-quality clinical research under the New Policy, tailored clinical research management system in our hospital was developed and implemented. And the hospital′s clinical research capability and level have been greatly improved, which enhancing the hospital academic influence, as well as its competence for serving the development of national and regional clinical research.
ConclusionsAlong with the rapid progress of clinical research, hospitals need to assure the compliance of national laws and regulations, and develop appropriate and applicable institutional management measures to empower the conduct of high quality clinical research.
Key words:
Investigator-Initiated Trial; Clinical research management system; Information management; Whole process management
Contributor Information
Zhu Qi
Changhai Clinical Research Unit, The First Affiliated Hospital of Naval Medical University, Shanghai 200433, China
Li Mengshi
Changhai Clinical Research Unit, The First Affiliated Hospital of Naval Medical University, Shanghai 200433, China
Jin Jing
Changhai Clinical Research Unit, The First Affiliated Hospital of Naval Medical University, Shanghai 200433, China
Gao Jinyuan
Changhai Clinical Research Unit, The First Affiliated Hospital of Naval Medical University, Shanghai 200433, China
Xue Qian
Changhai Clinical Research Unit, The First Affiliated Hospital of Naval Medical University, Shanghai 200433, China
