The Single Source Project uses standards for healthcare information (HL7) and standards for clinical research (CDISC) for the electronic source documentation of clinical trial data and the generation of medical records for patient care from a single point of entry.

This approach differs from traditional electronic data capture (EDC with eCRFs) and traditional electronic health record (EHR) systems by integrating clinical research data collection at an investigative site with minimal impact on existing workflow for patient care. This approach avoids the regulatory pitfalls inherent in the extraction of clinical trial data from EHR systems by tapping case record information at the source, during the original subject encounter. It uses open standards from CDISC and HL7 to pave the way for interoperability and data re-use without re-entry or manual transcription.

The expected outcomes are:

• facilitation of clinical trials for site personnel, therefore increasing scope of participation
• lessening of the data entry, verification and site monitoring time and costs for clinical trial sponsors and improvement of data quality at an earlier point
• ready access to timely clinical trial management information
• creation of a pool of reusable site/trial management and patient recruitment information that becomes a resource beyond the trial for which it was collected
• interoperability among relevant systems/technologies used in healthcare and the biopharmaceutical industry

The HL7 clinical document architecture (CDA), which is based on the HL7 RIM, and the CDISC operational data model (ODM) provide the interfaces with clinical and research systems. The ultimate goal is a single overarching data model to support both clinical research and healthcare.

A simplified figure of the single source concept is shown below.