An Advanced Method Of SAE Data Management And Performance Appraisal

Data management plays an important role in clinical trials. Efficient management of clinical trial data could ensure data accuracy, integrity, and consistency between the two databases.Currently, pharmaceutical companies usually use two separate database systems to collect clinical trial study data and safety data. It is apparent that SAE (Serious Adverse Event) reconciliation is unavoidable as long as two database systems are used.Purpose:Design and develop a single database system to collect, manage and report both clinical trial study data and SAE data, in order to eliminate duplicate SAE related data collection and SAE reconciliation.Method:1. Design iClinTrial data standards, database structure and database main functions based on clinical trial data management regulations, ICH guidelines, CDISC standards and ICH E2B data standards.2. Technology platforms for developing iClinTrial are:Processor:Intel Core2P84002.26G; Memory:DDR31G; Operating system:Windows XP; Programming software:Microsoft Visual Studio. NET2010; Programming language:Visual Basic.NET; Operating environment:Microsoft. NET Framework4.0; Database:Microsoft Office Access2007; Database connection method:ADO.NET.3. Test iClinTrial application and evaluate efficiency based on data from9clinical trial in different therapeutic areas.Results:1. Pioneered and developed a true "single clinical trial database system" by successfully integrateclinical trial database and safety database.2. Get the following conclusions after simulating the application of iClinTrial.a. Data entry.iClinTrial eliminates duplicate collection, while "dualdatabase system" exists duplicate collection in SAE-related data, and duplicate collection of each SAE takes more than6min.b. SAE reconciliation. iClinTrial eliminates SAE reconciliation, while "dualdatabase system" takes more than60hours to do SAE reconcilation..c. Safety reporting. iClinTrialgenerates reports directly out of AE or SAE tabulate, even could complete reporting under a click. However,"dual database system" needs to merge or modifydatasets before generate reports through programming in SAS.d. Data quality. iClinTrial eliminates SAE reconciliation, therefore it doesn’t has SAE reconciliation issues. However "dualdatabase system" leads to about1.27data discrepancies.per SAE during SAE reconciliation process.e. Human resource cost. iClinTrial eliminates duplicate collectiong and SAE reconciliation, therefore it saves cost on human resourse. However,"dualdatabase system"spend about U.S.$12,450(in U.S.) more on solving issues during SAE reconciliation.