Vault EDC can be deployed as a standalone application or integrated electronic source data
(eSource) with Vault eSource to record patient data directly into a mobile application.
The accumulation of electronic source data
and the evolution of electronic documents toward more dynamic forms that can combine written text, bookmarks, hyperlinks, and multimedia features create the need for digital archives and electronic signatures to preserve the integrity of originals.
As information is saved, its electronic source data
is captured and stored all in the same step.
If clinical patient data was collected only as electronic source data
, it would be possible to integrate that data into an EMR using healthcare interoperability standards such as Health Level Seven (HL7) data export or, alternatively, printing the electronic source data
and add it to the patient's medical record.
Food and Drug Administration (FDA or Agency) released a draft procedural guidance document relating to the conduct of clinical trials regarding electronic source data in clinical investigations that is intended to enhance the reliability, quality, integrity, and traceability of electronic source data.
Electronic source data are a subset of source data: those that were initially recorded electronically.