Data management at the Clinical Trials Unit

The King's Clinical Trials Unit Data Management team has extensive experience of designing, implementing and managing complex data management solutions for large scale randomised controlled trials. The services provided can range from advice on data management strategies to complete data management systems and data handling.

What database system does the Clinical Trials Unit use?

The Online Data Capture and Management Service uses MACRO, a system designed by InferMed (www.infermed.com), to set up and test a database tailored to the data capture needs of an individual trial – from single-site small projects to large, complex multi-site international trials with multiple treatments and multiple arms. The Service includes the creation of bespoke eCRFs (case report forms) that enable participating centres to enter their data securely online, and offers different access rights (data entry or monitoring, for example) and query facilities for trial managers. The system is easy to use, easy to monitor and easy to archive, and gives trial statisticians confidence in the accuracy of the data collected and control of the database lock procedure.

There are many commercial systems available, but within the cost restraints of many academic studies, MACRO is the best option available in-house (particularly for clinical trials) and it is available through the King's Clinical Trials Unit.

Infermed MACRO is a local UK based company recognised with the EHI 2011 ‘Excellence in major healthcare IT development’ Award for providing Digital Services to NHS patients in England (www.nhsdirect.nhs.uk).

In April 2012 Infermed were awarded the Queen’s Award for Enterprise in Innovation

If you would like a demonstration of the system, please contact the CTU to schedule an appointment. Demonstrations can be given within your department to individuals or groups.

Details of the InferMed MACRO system can be found here https:\\www.infermed.com


Why use the MACRO system?

Bespoke
Each database is custom made to meet study requirements

Easy to use
No installation packages required so users can be up and running quickly

Flexible
It can be used both offline or online for single centre or multi centre studies

Secure
Only specified users can enter/monitor/extract data

Regulatory compliant
MACRO has been designed to support the requirements of internationally recognised ICH Good Clinical Practice and FDA 21 CFR Part 11

Built in query management system
A clear audit trail is included as part of sophisticated data checking, cleaning and monitoring facilities

Integrated data validation check
Minimises data entry errors with integrated data validation functionality

Input/Output
Output to a range of packages including; Excel (CSV), Access, SAS and STATA. Want to analyse a small subset of variables? We can export subsets of variables into one spreadsheet. The system also has batch data import facilities

Efficient
Online data entry, monitoring and database locking facilities help to prevent errors and reduce time to analysis

Reliable
MACRO has a track record in commercial, academic and not-for-profit clinical research