HIRUZ Data Management Unit (DMU) implemented a Clinical Data Management Systems (CDMS) for electronic data capture in clinical research. Electronic case report forms (eCRF) are constructed to organize and integrate information from multiple data sources (e.g. questionnaire survey data, biologic laboratory data, vital statistics, and others). CDMS software enables ongoing surveillance of data quality and periodic reporting to monitor the progress of study deliverables. After initial study design in collaboration with the biostatistics unit, an eCRF is constructed to organize and integrate information from multiple data sources (e.g. baseline/demographic data, quality-of-life questionnaire survey data, biologic laboratory data and others).
The software is hosted on the campus on ICT UZ infrastructure to provide the best in data storage and security.
After development, we will provide a production check of the electronic versions of your study instruments to ensure a smooth launch of the data collection.
Data housed within the clinical research data management systems are accompanied by an automatically generated audit log, which records user, time/date and specific changes made by all users.
Research Electronic Data Capture (REDCap)
REDCap is a secure web application for building and managing online surveys and databases. Using REDCap’s streamlined process for rapidly developing projects, you may create and design projects by using the Online Designer and/or constructing a ‘data dictionary’ template file in a .csv spreadsheet, which can be uploaded into REDCap. Both patient surveys and databases can be built using these methods.
REDCap provides audit trails for tracking data manipulation and user activity, as well as automated export procedures for seamless data downloads to Excel, and common statistical packages. Also included are a built-in project calendar, a scheduling module, a double-data entry module, ad hoc reporting tools, branching logic, field validation, and more.
REDCap software is restricted in use, permitted only for non-commercial research purposes.