Clinical Research Document

Clinical Research Document describes the content pertinent to the clinical research use case required within the Retrieve Form for Data-Capture (RFD) pre-population parameter.

Summary

Clinical Research Document (CRD) is part of a set of profiles that create interoperability between EHRs and specialized research systems, resulting in EHR-enabled research. CRD is a content profile that works with the Retrieve Form for Data Capture (RFD) profile to enable a research coordinator to display a partially completed case report form within the EHR. CRD defines the pre-population data set that reduces the need for the study coordinator to re-enter data which may already exist in the patient's record. CRD leverages standard EHR export documents to accomplish this, and maps the EHR data to corresponding research formats as defined by CDISC's CDASH standard.

Benefits

CRD both saves labor and improves the quality of research data. By eliminating duplicate data entry, the use of CRD saves time in the process of completing a research case report form. By using existing EHR data to automatically pre-populate the form, CRD eliminates data entry errors, thus improving data quality.

Details

CRD is activated by the Retrieve Form for Data-capture (RFD) profile at the point where RFD retrieves a form from a research system such as an Electronic Data Capture (EDC) system. CRD defines the export document based on HL7's Continuity of Care Document, and provides a mapping to CDISC's CDASH standard.

Systems Affected

• Electronic Health
• Clinical Trial Management System

Specification

Profile Status: Trial Implementation

Documents:

http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_CRD.pdf

Supporting Standards:

• IHE Retrieve Form for Data-capture
• HL7 CCD
• CDISC CDASH