Taken from FDA Guidance Computerized Systems Used in Clinical Trials "Computerized systems should be designed: (1) so that all requirements assigned to these systems in a study protocol are satisfied; and, (2) to preclude errors in data creation, modification, maintenance, archiving, retrieval, or transmission.
Security measures should be in place to prevent unauthorized access to the data and to the computerized system"
Together the Programming and IT Support Teams cover all aspects of information provision, database design, support and informatics within the CRCTU. The Programming Team also provides consultancy services for external colaborators. measurement, pharmacy, imaging and GCLP-compliant laboratories.
Programming Team Leader
Mr Paul Mason
The team has a number of programmers, a database administrator and an informatics specialist.
Role of the Team
Provision of trial data collection using traditional paper or Electronic Data Capture (EDC).
Provision of randomisation services.
Support for trial and data management systems.
Provision of informatics support to the school, including integrated clinical and bio-informatics.
Our core systems are developed using ASP.NET with SQL server databases. These are supported by code generation tools using a structured metadata repository that enable rapid development of clinical trial management systems and support our informatics research work.
IT Support Team Leader
Mr Anthony Steer
The team has a total of three members of staff.
Role of team
Management of IT infrastructure underpinning the operational requirements of all clinical trials run by CRCTU
Provision of desktop support to all CRCTU Staff and trials.
Both Virtual and Physical Servers provide the backbone to the centralised IT infrastructure. Virtual servers are provisioned using VMware ESX and clustering, system replication technologies used to provide fault tolerance and disaster recovery capabilities to the CRCTU.