The Applied Research Of Validate Electronic Data Capture System In Clinical Trials

Objective: Through to the international pharmaceutical industry computerized system validation guide GAMP5's theory research,combined with the domestic and foreign related laws and regulations and guidelines,to discuss how to follow GAMP5 to perform complete and effective validation for electronic data capture system(EDC).In order to provide the feasibility and practical method to those enterprises or institutions which are lacking or don't establish the suitable validation system for the data management computerized system.Method:1.Through the theoretical research of GAMP5,puts forward the basic procedure,method and main content of validation for the EDC system.And put forward how to develop a computerized system validation practices.2.Through the research of the present application situation and the development of EDC system in the clinical trials,discussing the significance and necessity of validate the EDC system.3.Using Gooclin system as an example,a type of EDC system.Studying the concept of GAMP5,specify how to implement validation of electronic data management system.Firstly,establishing validation group and set up the SOP of validation.Secondly,according to the classification of hardware and software in GAMP5,classify the hardware and software of Gooclin system.Then assess the risk of this system.Forming a reasonable and operational validation protocol.Finally,according to the "V" pattern in GAMP5,validate Gooclin system,and form validation document.Results: We built a scientific and complete validation framework of Gooclin system by study the concept of GAMP5.Found there are many possible factors restricting the development of EDC system by studying the present application situation and the development of EDC system in the clinical trials,and discussed powerfully the significance and necessity of validate the EDC system.We have realized the application of GAMP5 in the clinical trials by validating Gooclin system.And we verified that Gooclin system is to meet the requirements of related regulations and business.Conclusion: To explore how to really understand the GAMP5 theory and related regulations and guidelines,based on the characteristics of different systems and requirements,set up for all kinds of clinical research computerized system for real scientific,reasonable and complete validation of the model or standard,is a key subject in the field of clinical trials in China.Only this problem solved,the so-called computerized system validation can be reasonably widely in the field of drug clinical trials in China,to better promote the development of clinical information.