Information systems and Data Management

The Information Systems and Data Management department provide an integrated Data Management service. This means seamless clinical data capture, validation, monitoring, storage, processing and archiving powered by the latest clinical research management technology.

All data management projects are devised in accordance with the PRINCE project management methodology and using clinical-research-specific study management software.

The team is led by an IT professional with over 15 years database management experience. The information systems team can provide data management expertise and IT support at every stage of the project. IT services provided by the CRFG include the development of Electronic Case Report Forms (eCRF), database design and ongoing data management.

Our Data Management team can aid in all or any of the following data management phases:

Case Report Form (CRF)

Develop new CRF from study/trial protocol in association with PI to capture the study/trial data
Electronic Case Report Form (eCRF) development
Development of eCRF user documentation
Provision of training on eCRF

Data Validation

Validation on every data field
Cross-field validation. E.g. If Sex is set to Male, Pregnancy cannot be set to Yes.
Validation reports to speed-up data cleanup
Perform database lockdown and extraction of data for statistics

Database Design 

Online, Anywhere, Anytime Data entry
Maximum data extraction from hospital databases (Automatic interface between Patient Administration system and Laboratory Management System)
Integration of adverse event coding systems (CTCAE)
Integration with Digital Pen technology to enable quick capture of paper-based data.
Integration with Speech Recognition systems (Dragon)
eCRF database is validated to FDA 21CRF Part 11 standard
Provision of 21 CRF Part 11 validation service for interfaced systems
Database testing
Main database is Distiller (Slidepath) but can support Caisis (Open Source), Microsoft Access, EpiInfo (WHO) and SPSS data builder

User Management 

Management of user accounts, removal of obsolete accounts
Assign permission at field, form and database level (read only, read/write and anonymised depending on role) 
Adherence to data protection best practice

Data discrepancy management

Data queries managed and resolved by the data manager 
Queries referred to research team using online query form 
Audit trails tracking all deletions, updates or additions to data after initial entry

Reporting

CRF submission tracked to agreed schedule 
Accruals monitoring and reporting 
Data quality reports 
Interim analysis reports 
Database lockdown and extraction of data for statistics
Archive the database on study completion

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