Table 1 List of requirements for a comprehensive data management based on [1]
No. | Requirement |
|---|---|
1 | Development of a data dictionary (DD) and electronic Case Report Forms (eCRF) for data capture |
2 | Generation and provision of web-based questionnaires in the form of eCRFs for central data collection |
3 | Separation of personally identifiable information (PII) [5] as well as medical research data (MDAT) including the generation of pseudonyms as early as possible within data processing |
4 | Separate storage of metadata and pseudonymized MDAT |
5 | ETL-processes: extraction of relevant data from connected data sources, transformation of the data to a uniform (internal) data format, the enrichment of metadata and the loading of the enriched data into the research data repository |
6 | Export and transfer of uniform, pseudonymized data in at least one standardized format (e.g. SPSS or SAS) for data analysis and/or quality assurance |
7 | Ensuring the possibility of authentication (managing users as well as roles and/ or rights) as well as study process and site management |