Background to the Clinical Research Database

This database was developed to underpin the work of the clinical group in an Oxford biotechnology company.

On a daily basis the Clinical Research Scientists work with multiple sites across the world to recruit patients and to collect data from the testing of their medical devices. The data are collected on multiple questionnaires and hard-copies of the forms are filed. The patient data form the basis of the application to seek approval from the Food & Drug Administration (FDA) to market the devices in the USA. Consequently it is crucial that the data are stored securely to maintain data integrity.

Features

Data security is accomplished at various levels. Firstly, each user has a user name and password to access the database. Secondly, users are allocated to ‘security groups’ that have associated rights of access. Thus, when a user logs on to the database, certain functions may be disabled so that the user is prevented from viewing sensitive data. Finally, a full audit trail has been created that tracks user actions, such as editing records.

Database navigation occurs via the menubar, which reflects the concept of the modular design. Users may browse records for the three modules: patients, samples and plates with results. Patient samples may be allocated to a 96-well plate and analysed for reactivity to the test. An additional database module serves as a contacts organiser. In the current context, the contacts and organisations contain hospital, general practitioner, consultant and site enrollers.

Additionally, the database has special screens for:

• data import 
• data export 
• archiving records 
• searching  
• reports  
• security  
• system functions  

To this day, the Clinical Database is the focus of the clinical team enabling them to run streamlined patient trials.

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