Data monitoring and management
CTCM, CRF
CRF
Despite the fact that this study will be conducted in a paediatric population, the implementation of a Data Management Committee is not indicated. This decision was mainly based on the fact that the intervention of the study (probability diagnosis based on the breath test) provides caregivers and treating physicians with disease-specific treatment recommendations, but does not obligate them to adhere to a specific treatment protocol.The ADEM2 database is developed by the Clinical Trial Centre Maastricht (CTCM) in collaboration with MEMIC (centre for data and information management at the Faculty of Health, Medicine and Life Sciences of Maastricht University and MUMC +). CTCM is one of the leading Academic Research Organizations (ARO’s) in the Netherlands, and provides services to facilitate research, including the set-up of databases that meet the highest quality standards and newest guidelines. The data are collected by using the CASTOR application, an electronic tool that is adapted to the ADEM2 requirements. Data are collected by using the CTCM coding, which can easily be supplemented with an International coding (for example SNOMED). Metadata is included in the application of the electronic Case Report File (CRF) (CASTOR). This includes, for example, the units that are used, but also the coding of the variables. Data is securely stored for 15 years at CTCM. CASTOR provides export to various data formats, including SPSS, SAS, XML, CSV and Excel. By using CASTOR, the data collected in ADEM2 are according to the FAIR (Findable, Accessible, Interoperable and Reusable) criteria. By using clear coding with metadata and having the possibility to export the data to different formats, the data are interchangeable and reusable.