EHR-integrated EDC-system x4T-EDC: Exchange for Trials)
Electronic data capture (EDC) systems are usually separated from Electronic Health Record (EHR) systems in which routine patient care documentation is done. To overcome the drawbacks of redundant, error-prone and time-consuming double documentation, we have designed, implemented and integrated EDC system called “exchange for Trials” (x4T-EDC) according to the single-source approach.[1,2] This system allows the documentation of routine care and research relevant documentation within the EHR system. After data validation it is automatically transferred into x4T-EDC. Direct connections to pseudonymization services is also possible within x4T-EDC and the EHR system.
The framework development and evaluation was supported by German Research Foundation (DFG).