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Data Management System

A  Foundational functions

 --Double data entry

 --Double data comparison and validation

 --Laboratory reference range management

 --Query & query resolution

 --Coding

 --Data lock

 --Data unlock

 --CRF tracking   

B  Study data base options

--Microsoft Access for small size clinical trial

--Microsoft SQL Server (free MSDE 2000), It’s strongly recommended to use SQL Server as the study data base when patients number is larger than 500

--Oracle (Oracle database is not embedded in ClinStReport Data Management System as the above two database are, You can order Oracle database but you should purchase Oracle license first) 

C  Securities

 --Password protected logon

 --Password protected data base

 --Restricted visit to the media where database resides

 --System administrator can not access study data 

D  Data base backup

 --Automatic backup data base when Microsoft Access data base is used

 --Backup/restore application for Microsoft SQL Server/Oracle  database

E  Coding dictionary

 --Default dictionary will be the Chinese dictionary for adverse event issued by SFDA

 --MedDRA/WHO DD can be ordered as required 

F  Audit trails, below information will be recorded

 --Trails of database login

 --Trails of data entry

 --Trails of data change

 --Trails of data deletion

 --Trails of data unlock 

G  Data extraction

 --Extract study data to SAS according to the standard of relational database 

 --Extract audit trail to Microsoft Excel 

H  Data exchange/importation

 --Data exchange application can be add-in after project specified data exchange standards setup 

I  Flexible and convenient of system design and maintenance

 --Data entry screens, data tables are read-in from annotated CRF text

 --Variables can be added to/deleted in any data entry screen without damaging data already entered

 --New CRF Page or extra page can be added without requiring system re-design

 --Any change made in terms of variable or CRF Page adding/deletion will not require   rewriting of data extraction  programs

J  Simple procedures in system validation

 --Specially planned system is divided into two modals, the designing modal and the working modal,   the working modal initialize clinical trial project by reading-in the study setup information from the designing modal, thus mostly simplify the procedure of system validation 

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