Strategies and measures for improving the quality of Investigator-Initiated Trials / 中华医学科研管理杂志

ABSTRACT

Objective:To explored how medical and health institutions can improve the quality of Investigator-Initiated Trials(IIT).Methods:Strategies and measures were proposed to ensure the quality of IIT based on the combination of related literature review and IIT management experiences analysis.Results:Institutions can carry out following measurements to improve the quality of IIT, which include setting up tailored IIT management department, establish centralized management system; conducting systematic regulatory and clinical research methodology trainings; develop effective quality control system and quality assessment index, applying electronic information system and platform to optimize the management.Conclusions:Strengthen the standardized management is an effective strategy to improve the quality of IIT in medical and health institutions.