Data Management

Data management is increasingly becoming a key topic when performing (clinical) studies for the development of medical products and was thus given high priority in the CLINICIP project – from data acquisition to data storage to data access.

The data from all single centre and multicentre clinical trials performed during the project were entered into a knowledge and data sharing environment, which was implemented using proven database technology. The introduced data collection workflow included several ways of importing and processing different data sources – both paper based and electronic, such as case record forms, Excel files or outputs from patient data management systems or from the eMPC algorithm. A secured web application provides access to the data, which can be exported on a single patient or cross-study basis.

The data management system and procedures fulfil the ISO-14155 standard following the Medical Device Directive and will be used in the planned device registration procedure.