Thinking and practice of risk-based monitoring strategies in Investigator initiated Trials
10.3760/cma.j.cn113565-20230106-00003
- VernacularTitle:基于风险监查策略在研究者发起的临床研究中思考与实践
- Author:
Baoshi YUAN
1
;
Yinkai WANG
;
Ruyue NI
;
Wei LV
;
Xia MENG
Author Information
1. 首都医科大学附属北京天坛医院 100070
- Keywords:
Investigator initiated Trial;
Risk based monitoring;
Project management
- From:
Chinese Journal of Medical Science Research Management
2023;36(3):182-188
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To discuss the scientificity and feasibility of risk-based monitoring strategies in Investigator initiated Trials.Methods:" Guideline for Good Clinical Practice" promulgated by NMPA, " Oversight of Clinical Investigations-a Risk-based Approach to Monitoring" and " A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE" promulgated by the US FDA and other documents were analyzed, the practical experience of Investigator initiated Trials was also summarized.Results:It was recommended that clinical investigators use risk-based monitoring strategies in Investigator initiated Trials. The main idea of risk-based monitoring is to determine the key process and key data of the study, carry out risk rating on the project, and adopt corresponding monitoring methods according to the risk level when formulating the monitoring plan. At the same time, during the clinical trial development process, the risk and data quality of the research center should be regularly evaluated to grasp the risk changes of different centers. In accordance with trends, adjust the method, content and frequency of monitoring.Conclusions:To apply risk-based monitoring strategies in Investigator initiated Trials is scientificity and feasibility. Risk based monitoring can meet the data quality requirements of clinical trials, without affecting the analysis results of the main outcomes, and can further improve the efficiency and effectiveness of monitoring.
