The Structured Data Capture (SDC) Initiative seeks to link clinical data, captured within the Electronic Health Record (EHR) system during clinical encounters, to supplemental systems that collect structured patient data within forms. For example, consider a clinician treating a patient who is participating in a clinical trial or comparative effectiveness research (CER).
First, the EMR displays the electronic case report form (eCRF) to the clinician through the EHR user interface. Some information in the eCRF would be automatically populated with current data derived from the EMR, and the remainder of the form's data would be entered in response to standardized questions posed by the eCRF. The eCRF data will be captured in a structured form, and ultimately aggregated and transferred to end users as required for the particular use case.
SDC requires that the question/answer (data element) structure of EMR forms be specified in a standardized, interoperable and reproducible way. As a consequence, SDC requires the definition of metadata for forms and data elements, in a manner relevant to EHRs and entities using EHR data. Therefore SDC aims to leverage synergistic government and health care industry efforts underway related to standards definition, and representation to facilitate capture, reporting, and analysis.
The standards and guidance incorporated into this implementation guide are based on the requirements defined in the Structured Data Capture Initiative Standards and Interoperability Framework Use Case document. Users of this implementation guide will benefit greatly from review of the SDC Use Case document.