Exploration To Key Factors Of Electronic Data Management Of Traditional Chinese Medicine Clinical Research

The quality of clinical research directly affects the authenticity and reliability of the result, therefore, to build quality control or assurance system is one of the most important measures to ensure the quality of clinical research, in which data management is the crucial link. In the1990s, the development of electronic data capture (EDC) technology greatly promoted electronic clinical data management. Electronic clinical data management can improve the data quality, shorten the development cycle and save cost. It also plays an important role in the process of quality control and remote management of clinical research. Implement of electronic data management in clinical trials is imperative in the near future.Objectives1. Based on questionnaire survey, analyze the present status and tentatively explore a quality evaluation method of the electronic data management of TCM clinical research.2. Based on a case study, offer proposals to regulate electronic data management of TCM clinical research.Methods1. To investigate by questionnaire survey in13clinical research bases of TCM and analyse the data by statistical description.2. Rating13clinical researches by both the quality control evaluation method of the electronic data management and the existed quality control evaluation method of whole process quality.Comparing them by wilcoxon matched-pairs signed-ranks test and correlational analyses.3. Use electronic Data Management in a new drug clinical research and analyse the process of data management by statistical description.Results1. Status survey95%of TCM clinical researches use electronic data management systems. Except for one Oracle system, others are domestic. Others are as follows:System performance:(1)85%of the system support double entry reconciliation,69%remind the abnormal lab values, and54%remind missing or contradictory values.(2)Role assignment:85%can assign multiple roles.(3)Audit trail and security assurance:31%have no any audit trail,46%support data backup,46%have electronic signature when submitting or modifying data.Only38%can entry data timely,46%conduct source data verification and62%clean data when the study was finished.85%had independent folder,62%had data management SOP and data management plan.More than half did not have data validation plan, test report of check, data management report.2. The quality control evaluation methodThe preliminary quantitative indicators of The quality control evaluation method for electronic data management consists of7essential factors and14indicators.The result of wilcoxon matched-pairs signed-ranks test is that two kinds of ranking have no difference(P=0.9441), the result of correlational analyses is that they have positive correlation relationship (rs=0.591,P=0.0312).3. Case studyData by single entry was entered nearly after all the patients included. It took35days to lock database after all the data entered. Compared with another double-entry research, although they have almost the same entry error rate(1.79%vs1.55%), errors of the first were completely found by SDV, but87%in the other one were found by double-entry check. Electronic data management took97hours solving a question on average. Due to no communication plan and the crowded schedule of the doctors, receiving questions took up one-third of the time.263questions were sent automatically. Because of the defect of CRF designing, the top two types were contradiction and data missing.(l)According to the time of dispensing medicine, two subjects messed with the randomness.(2)11subjects broadened therapeutic window.(3)24subjects from8centers violated the inclusion or exclusion criteria, including2subjects did not satisfy the standard of TCM, the age of4subjects was not qualified and18subjects had abnormal lab values.(4)16subjects took other18kinds of Chinese or Western medicines.3subjects took medicines prohibited by the proposal.(5)23AE were reported, and other abnormal lab values were required to report AE at the end of study.Conclusion1. At present, the quality of electronic data management of TCM clinical research is low and the related documents are incomplete. Home-made systems are used in these projects and need to improve in validation, data traceability and safety.2. Electronic data management plays an important role in process quality control of TCM clinical research. The preliminary quantitative indicators of quality control evaluation method are rational.3. There are some key factors in electronic data management of TCM clinical research:(1) the choice of EDC system;(2) proposal design;(3)CRF design;(4)effective training;(5) the way and the timeliness of data entry;(6) checking inclusion and exclusion criteria and the concomitant medicine;(7) effective communication;(8) QC and QA;(9) time saving for doctors;(10) standardization and coding.