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 an EHR and specialized research systems, resulting in EHR-enabled research. CRD is a content profile that works with the Retrieve Form for Data Capture 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
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- PACS systems may store, manage, and/or display Evidence Documents.
- Display systems may query, retrieve and display Evidence Documents.
- Reporting workstations may retrieve, process and include details from Evidence Documents in reports
Actors & Transactions:
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Specification
Profile Status: Trial Implementation
Documents:
- HL7 CCD
- CDISC CDASH
See Also
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Related Profiles
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- Reporting Workflow [RWF] may use Evidence Documents as inputs to the reporting process.
- Simple Image & Numeric Reports [SINR] may include data copied from Evidence Documents.
- Cross-enterprise Document Sharing for Imaging [XDS-I] can be used to share Evidence Documents between sites over a network.
- Portable Data for Imaging [PDI] can store Evidence Documents on media such as CDs.
- Import Reconciliation Workflow [IRWF] can fix patient ids, etc. of Evidence Documents when importing.
Consumer Information
The Profile FAQ Template answers typical questions about what the Profile does. <Replace the link with a link to the actual FAQ page for the Profile>
The Profile Purchasing Template describes considerations when purchasing equipment to deploy this Profile. <Replace the link with a link to the actual Purchasing page for the Profile>
Implementer Information
The Profile Implementation Template provides additional information about implementing this Profile in software. <Replace the link with a link to the actual Implementation page for the Profile>
Reference Articles
<List References (good and bad) (with link if possible) to Journal Articles that mention IHE's work (and hopefully include some analysis). Go ahead, Google: IHE <Profile Name> abstract or Google: IHE <Profile Name> and under the "more" select "Scholar". You might be surprised. >
This page is based on the Profile Overview Template