ClinStReport CDM Sysytem is a Oracle/Microsoft SQL Server based clinical data management system, which meets the requirements of US FDA 21 CFR Part 11(Electronic Records & Signatures).
Foundational functions
　

Double data entry

Double data comparison and validation

Laboratory reference range management

Query & query resolution

Medical coding

Data lock & unlock

CRF/Query tracking

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)

Securities

Password protected logon

Password protected data base

Restricted visit to the media where database resides

System administrator can not access study data

Data base backup

Automatically backup data base if Microsoft Access database

is used

Backup/restore application available for Microsoft SQL

Server/Oracle database

Coding dictionary

Default dictionary will be the Chinese dictionary for adverse

event issued by SFDA

MedDRA/WHO DD can be ordered as required

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

Data extraction

Extract study data to SAS according to the technique standard

of relational database

Extract audit trail to Microsoft Excel

Data exchange

Data exchange application can be add-in after project

specified data exchange standards setup

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 to rewrite data

extraction/exchange programs

Simple procedures in system validation

Specially planned system is divided into two modals, the

designing modal and the working modal, the working modal is

initialized by reading-in the study setup information from the

designing modal, thus mostly simplify the procedure of system

validation