The potential link between the information underlying patient healthcare and clinical research remains largely untapped. Information that could benefit all parties---patients, physicians, investigators, regulators and biopharmaceutical product developers---remains in disparate databases and paper records.

Over 75% of clinical trials are conducted using paper data collection, according to a recent study conducted jointly by the Clinical Data Interchange Standards Consortium (CDISC) and CenterWatch, despite overwhelming support for the concept of electronic data capture. Several factors have been responsible for the failure to move information efficiently between clinical and research settings:

- lack of standards

- unclear regulatory climate

- failure within the clinical setting to adopt electronic health records

This paper describes a collaboration among the Duke Clinical Research Institute (DCRI), Duke Clinic and CDISC demonstrating that single-source documentation can generate data streams to serve the needs of both health care delivery and clinical research. This proof-of-concept takes advantage of two converging standards, Health Level Seven's Clinical Document Architecture (HL7 CDA) and the CDISC ODM (Operational Data Model). While novel in the context of healthcare information and clinical trials, many aspects of the approach are very close to well-established XML-based publishing workflow and document management.

The current paper-based process for collecting clinical trial data is inefficient and error prone. It requires that data be entered by hand, typically on a three-part paper case report form (even if it is already in an electronic record), from which it is re-entered once or even twice into a clinical trial database before it is evaluated for errors/inconsistencies. In contrast, the standards-based and technology-enabled single-source process can reduce transcription errors, increase efficiency and facilitate information flow and timeliness of data, thus improving data quality and patient safety.

Unlike previous attempts at electronic data capture, this project fits in with current workflow, uses a document-centric view of the healthcare record that does not presuppose existence of an electronic healthrecord and uses open, XML-based standards.

In the US, Food and Drug Administration representatives are active in the development of standards for regulatory review and warehousing of clinical data. They require that data be submitted in SAS transport files and pdf formats today, but have expressed an interest in moving to XML once appropriate standards and tools are available. FDA, CDISC and HL7 have been collaborating for over two years through a technical committee formed within HL7 (Regulated Clinical Research and Information Management RCRIM). A common informatics platform for healthcare and clinical research is one area of RCRIM interest.

This approach collapses two or three data capture steps into one, with the attendant efficiencies. It will also retain the source separately from the clinical trial data and maintain site control over these data, an important regulatory consideration. The demonstration takes advantage of two converging standards, HL7 CDA and CDISC ODM, and provides the first direct link between them.