ABSTRACT
Objective By analyzing the problems existed in the Investigator Initiated Trial (IIT),this article put forward the corresponding countermeasures and therefore provides reference for the standardization of clinical research project management.Methods Four types of problems identified in the supervision of hospital IIT projects are analyzed according to literature review,data analysis of clinical research project,comparative study and summary.Identified problems are existed in the following aspects:scientific research supervision function,research method guidelines,technical specification of the diagnosis and treatment,scientific research design and project approval review,research funds,medical ethics committee,construction of Biobank and Regulation Conflicts.Results This article put forward 6 countermeasures for improvement:establishing and perfect IIT project scientific research supervision entity,bring in the IIT project steering group to strengthen the scientific review;Strengthen risk management to ensure medical safety,carry out IIT training,establish IIT management database information system,build a comprehensive integrated development multi-point application model of hospital BioBank.Conclusions The establishment of the hospital's IIT scientific research supervision system,management mode and technical standard system is of great importance to standardize clinical research,ensure research quality and guide the clinical research work of the hospital effectively.