Development And Application Of Clinical Trial Quality Management System

Research Objective: Based on the use and investigation of the previous clinical trial management system,especially for the design defects and deficiencies of the domestic clinical trial project management information system,the research design meets the quality management needs of the whole process of clinical trials.Form a clinical trial quality management system with its own characteristics,in line with Good Clinical Practice and 21 CFR Part 11,and apply it in project quality management.Improve the quality management ability of the whole process of clinical trial projects,improve the quality of the whole process of the project,and ensure that the project is completed in accordance with the standardized,efficient and high-quality research plan.Research content: The whole process of clinical trial involves many units,institutions and roles with different functional divisions,so the management system needs to cover many functions and is a huge information system.This project starts from six major sections,including center management,personnel management,document management,progress management,financial management,and quality management,and designs an information-based clinical trial project quality management system that can be connected to each project to improve the quality of clinical trials.Research Methodology: This project is conducted in the following steps:Step 1: To conduct business requirement research based on the existing clinical trial management system and the common problems in project management.Collect,count and analyze the business requirements of all nodes,personnel,data and documents involved in the whole process of clinical trials.Initially determine the overall design framework of this system.Step 2: Establishment of the construction plan of the clinical trial quality management system.Standardized core function design.Complete the project management requirements,workflow design for each role,underlying logic,module building,etc.for system construction.Step 3: System testing and validation.Test whether the functions are achieved in the test environment for each role,work node,data and document generation,etc.The system is validated according to the "Clinical Trial Quality Management System＿V1.0User Manual",the "21 CFR Part 11 Checklist" of the Food and Drug Administration(FDA),the general principles of FDA software validation and other related guidelines.After the validation,the system can be released to the production environment for practical application.Step 4: System application.After pre-development design,testing,and validation,the system will be applied and evaluated in a randomized,double-blind,placebo-controlled Phase I clinical study.Innovations: Based on project management theory and the whole process management of clinical trials,realize a safe,reliable electronic clinical trial quality management process that conforms to the workflow of program manager,clinical research associate,quality control and other personnel,so as to improve the quality management ability of the whole process of clinical trials and improve the quality of the whole process of the project.