Information systems and database development

We work closely with study teams in order to deliver a bespoke system which best supports the specific needs of the study and the study team. Depending on the size and shape of the study, our systems support three distinct requirements:

• Clinical management: Processes which support clinical data management (including data entry, validations and randomisations)
• Participant management: Processes which improve the management of a participant’s progress and activities throughout a study (including scheduling appointments and triggering follow-ups)
• Study management: Processes which bring real-time visibility to how the study is performing (including participant recruitment reporting).

All systems have the clinical management module as its core. The participant and study management modules are added if and when the study requires them. We favour an electronic case report form approach wherein we front-load the system with validations which ensure data quality is as high as possible and downstream data cleaning is kept to a minimum.

Irrespective of the technology we use, or the size and shape of the study, the same SOPs and policies are used. We have a number of SOPs which cover all stages of the IS lifecycle covering:

• Requesting a new system
• The design and build of a new system
• Peer review of a new system
• User acceptance testing of a new system
• Live support of a system
• Change control of a system
• Locking and archiving of a system.

Once live we follow standard change control and version control procedures.

The broad footprint of work the team supports has resulted in us using a range of technologies to best tailor a system to support a study. All databases are Microsoft SQL Server but the software and hardware which interact with the database can vary. Therefore, we use a mixture of:

• MACRO4 (through our relationship with Cancer Research UK we are collaborating with other clinical trials units on developing best practice for using this software).
• Bespoke languages (such as PHP, C#, HTML and JavaScript) which we use to create online forms, randomisations, validations and processes to improve the speed and quality of data collection.
• Teleform (which enables us to scan paper case report forms directly into a database).

As studies can run for a number of years, we support a mixture of both current and legacy technology. We are assisted in this by the Centre for Trials Research's information technology and business information team (who are responsible for the hardware and software across the Centre) and Cardiff University’s central IT team.

We also actively support use of mobile devices such as Google Nexus and iPads to collect data at site. We have several studies where this approach has been used and the response has been very positive, both in terms of system performance and data quality.

We recently published a paper entitled ‘Integrating technology into complex intervention trial processes: A Case Study’.

The information systems and database development team is headed up by Gareth Watson and currently consists of eight members, all trained in good clinical practice (GCP). Combined we have almost 40 years’ experience of working in a clinical trials unit environment (and over 100 years general IS and IT experience from both the public and private sector). Whilst we have a set of core skills we also have subject matter experts in software such a MACRO, languages such as PHP and HTML and databases such SQL Server and Oracle.

Each new study is assigned an Information Systems Lead Developer who interacts with the Study Team on behalf of the Information Systems and Database Development team. Some systems are built solely by the Information Systems Lead Developer whereas others are a combination of Information Systems and Database Development resource.