[Data documentation and data management with guidelines, experiences, caveats, and recommendations]

Reliable and correct data capture and safe data management are an inevitable prerequisite to gain valid data in clinical studies. The biostatistical analysis is the basis from which medical consequences about efficacy and safety of the treatment can be driven. The functional role of data capture and data management in relation to the study protocol, development of report forms, data flux between the involved institutions, and the data capture systems will be investigated. Main points of the data capture are the rationale of the study, the protocol, and the statistical analysis plan. Modularity, uniqueness, and reduction on the needs of the study protocol designate a good documentation form. Practical considerations will be given. Prompt and efficient communication between all involved participants is the organizational prerequisite for valid data, independent from the data capture system. Online data capture will displace the classical paper documentation form, however, accurate and careful documentation will remain. Data capture and data management are a crucial and cost-intensive chapter of a clinical study, formed by the technical ability and the team play of clinical principal investigators, biostatisticians, computer scientists, monitors, and the organizers of the study.