1. Structured Data Capture (SDC)
The Use of Structured Data Capture for Clinical Research
March 2016 S&I Initiative Coordinator: Ed Hammond
HHS/ONC Sponsor: Farrah Darbouze
DRAFT: Not for distribution

2. What is Structured Data Capture (SDC)?
The SDC Initiative defines the necessary requirements (including metadata) to facilitate the collection of supplemental EHR-derived data.
The SDC standards and guidelines are explained in two Implementation Guides – IHE SDC Profile and FHIR SDC Profile
Defines a structured form definition model
Template that can be used for creating forms for different domains making them interoperable
Guidance for structured Data Element definition model
SDC is not creating new Data Elements, however it defines structure (provides template) to create / edit Data Elements
SDC extends the value of EHRs by using Health IT systems’ data and interoperability standards to facilitate reporting

3. SDC Overview
Launched in 2013 in collaboration with NIH (NLM, NCI), AHRQ, FDA, CMS and CDC
Uses the structured data within EHRs to supplement data collected for other purposes, such as:
Clinical research (Patient Centered Outcomes Research/ Comparative Effectiveness Research) (NLM)
Patient safety event reporting (AHRQ) & Adverse Event Reporting (FDA)
Public Health Reporting (CDC)
Determination of Coverage (CMS) 3
DRAFT: Not for distribution

4. Value and Benefits
Reduce the data collection burden on health care providers.
Improve clinical research by leveraging data already in EHRs.
Implement published interoperability standards.
Contribute to and encourage the use of learning health systems.
Improve comparability of data to better inform research, quality reporting and ultimately, improve patient care.
Contribute to the Public Health, Patient Safety Reporting, Adverse Event Reporting, and Clinical Research communities by identifying trends, predicting outcomes, influencing patient care, drug development and therapy choices.
Contribute to projects which support more effective use of informatics (e.g. registries, cohort identification, and shared data across multiple sites to provider larger research cohorts).

5. SDC Standards Focus SDC Implementation Guidance
SDC Initiative has adopted and enhanced existing standards for:
Forms (also called templates)
Data Elements on those forms
Pre-population / Auto-population of the forms
Transport (how EHRs exchange forms)
These standards/guidelines are explained in two Implementation Guides:
IHE SDC Profile
FHIR SDC Profile
Standard for the structure/definition of the Data Elements (DEs) that will be used to fill the specified forms or templates
Standard for the structure or design of the form or template (container)
Standard for how EHRs exchange the form or template
Guidelines to pre-populate and auto-populate form or template with existing patient data
There are two version of this group of standards.
SDC IHE Profile
SDC FHIR Profile
The structured standard for the DE’s is based on ISO/IEC (and is also part of the IHE SDC Profile); the FHIR SDC Profile includes a NEW DataElement Profile based on DataElement Resource
The structured standard for the FORM is based on ISO/IEC (and is included in the IHE SDC Profile); however the FHIR SDC Profile uses Questionaire/Answer Resource which are based on the same SDC conceptual model
The standard for how EHRs exchange the form is in BOTH the IHE and the FHIR profile, but is different in each
The guidelines for pre-populating / auto-populating the form is in BOTH the IHE and the FHIR profiles 5
DRAFT: Not for distribution

6. Structured Data Capture Structured Data Capture Workflow Metadata
CDE Library
Sends request for form/template 1
Form/Template
Repository
Form Library
Metadata
Source
Sends requested form/template 2
SDC Scope
EHR System
Specified
Form/Template 3
Converts, populates and displays form 4
Fills, stores/transmits structured data
External Data Repository
Displayed
Form
Actor Key
Extract, Transform,
and Load Data by form/ template 5
Forms Filler
Structured
Data Capture
Forms Manager
External Repository
DRAFT: Not for distribution

7. SDC Transactions There are 3 Form Transaction Options: Blank Form
EHR System sends a request for a blank form/template to the Form/Template Repository
Form/Template Repository sends requested blank form back to the EHR System
Partially Completed Form
EHR System sends a request for the form/template with relevant patient data to the Form/Template Repository
Form/Template Repository sends the form/template with pre-populated patient data back to the EHR system
Completed Form
EHR System sends a completed form/template to an External Data Repository 7
DRAFT: Not for distribution

8. SDC Roles and Descriptions
Profile Role
Description
Business Role
Form Filler
Retrieves forms from a Form Manager as and when required. When requesting a form, the Form Filler can optionally provider EHR context information by providing pre-population xml data in the request for use by the Form Manager.
Health IT System (EHR/EMR)
Form Manager
Supplies forms to Form Fillers based upon form retrieval requests. In some cases, may return a form whereas in other cases the returned form may be selected or constructed based upon context information supplied in the form retrieval request.
Form Repository
Form Receiver
Receives and processes completed or partially completed forms instance data from a Form Filler.
External Data Repository
DRAFT: Not for distribution

9. Published in September 2014
IHE SDC Profile
IHE
SDC Profile
Published
Guidance
Part of IHE’s Quality, Research and Public Health Technical Framework (Revision 0.1)
Published in September 2014
Provides specifications to enable an Electronic Health Record (EHR) system to retrieve a form, populate it with existing data, add additional data, then submit the completed form.
DRAFT: Not for distribution

10. IHE SDC Profile Milestones
Balloted IHE SDC Profile through QRPH – Aug 2014
Published – September 2014
IHE Connectathon Participation – January 2015
HIMSS Participation – March 2015
Change Proposals Approved – July 2015
Form Definition Schema Updates – Sept 2015
Revised IHE SDC Profile Published – October 2015
IHE SDC Pilots kickoff – October 2015
IHE Connectathon Participation – January 2016
HIMSS Participation – March 2016

11. SDC Participation at the IHE NA Connectathon 2016
SDC community stakeholders successfully tested the SDC IHE Profile (current published version) at the IHE NA Connectathon
Forms prepared for NA Connectathon 2016 testing
Demographic Form (successfully tested through complete workflow)
Adrenal Form (unable to test due to time constraints)
Medwatch 3500 Form (unable to test due to time constraints)
Organization
Role
Form Successfully Transmitted
Epic
Form Filler
Demographic Form
NextTrials
Form Manager
CDC (eMaRC Plus)
Form Receiver
CA DoH

12. FHIR SDC Profile Based on the HL7 FHIR 1.0.2 / DSTU 2 Standard.
Published
Guidance
Based on the HL7 FHIR / DSTU 2 Standard.
Published in October 2015
Supports clinical systems in the creation and population of forms with patient-specific data.
Defines a mechanism for linking questions in forms to pre-defined data elements and enables systems to automatically populate portions of the form based on existing data (from an EHR or other system).
DRAFT: Not for distribution

13. FHIR SDC Profile Milestones
Kickoff for FHIR SDC Profile – May 2014
Draft for Comment Ballot – September 2014
1st Virtual Connectathon – April 2015
DSTU Ballot – May 2015
2nd Virtual Connectathon – August 2015
DSTU published – September 2015
Test track in the FHIR Connectathon – October 2015
FHIR Connectathon Participation – January 2016
HIMSS Participation – March 2016
FHIR SDC Pilots will kick off – Spring of 2016

14. SDC Participation at the HL7 FHIR Connectathon (Jan 2016)
SDC Community members participated in and successfully tested the SDC FHIR Profile (DSTU v2.1) at the HL7 FHIR Connectathon in January 2016.
Forms prepared for FHIR Connectathon 2016 testing
FHIR Test Form - Demographic (successfully tested through complete workflow)
Lung Cancer Form (successfully tested through complete workflow)
Organization
Role(s)
Forms Transmitted?
CCO (Cancer Care Ontario)
Form Designer
Yes
NCI (caDSR)
Form Designer / Form Manager
N/A
JBS
Form Manager / Form Receiver
Lloyd McKenzie
Form Filler
CDC (eMaRC Plus)
Form Receiver

15. SDC IHE Profile vs. SDC FHIR Profile Which standard is best suited to your needs?
Part of IHE’s QRPH Technical Framework (Revision 0.1)
Published in September 2014
Enables systems to retrieve a form, populate it with existing data from EHRs or other clinical systems, add additional data, then submit the completed form.
Content & Structure Standards:
ISO/IEC (data elements)
ISO/IEC (forms)
Transport, Security & Authentication Standards:
IHE RFD
IHE ATNA
SOAP
TLS v1.0 or higher
SAML
Based on the HL7 FHIR / DSTU 2 Standard.
Published in September 2015
Enables systems to create a form, link questions on the form to pre-defined data elements and populate portions of the form based on existing data.
Content & Structure Standards:
FHIR Data Element Resource
FHIR Questionnaire Resource
FHIR QuestionnaireAnswer Resource
FHIR ValueSet Resource
Transport & Security Standards
REST
SDC Security Consideration

16. SDC Pilot Activities Current IHE pilot participants include:
(UCSF) University of California San Diego
(CAP) College of American Pathologists
(DCG) Data Consulting Group
(CCR) California Cancer Registry
(CDC) Center for Disease Control
Expected Completion Date: August 2016
In the process of kick starting FHIR Pilots
Currently have proposals – hope to make decision in next week
Expected Completion Date: September 2016

17. SDC Participation Opportunities
HealthCa.mp On FHIR Code-a-thon
April 1-2, 2016 (Washington, DC)
We will be in attendance to support participants who will be testing the FHIR SDC Profile.
IHE F2F Meeting
April 25-29, 2016 (Oak Brook, IL)
We will be working on updating the IHE SDC Profile to include updated version of the form definition model and have the profile ready for public comments
HealthDataPalooza 2016
May 8 – 11, 2016 (Washington, DC)
We will support any SDC related activities during this event.
HL7 Working Group Meeting 2016
May 8 – 13, 2016 (Montreal)
We will be participating in and supporting the SDC track during the HL7 FHIR Connectathon.

18. Contact Information
Initiative Coordinator: Dr. Ed Hammond )
Federal Lead: Farrah Darbouze
Federal Lead: Mera Choi
Project Manager: Jenny Brush
Technical and Harmonization Lead: Vijay Shah
Harmonization Support: Perri Smith )
CDE Subject Matter Expert: Robert Hausam
FHIR Subject Matter Expert: Lloyd McKenzie
SDC Wiki Page:
Weekly All-Hands Meeting Info (Thursdays):
Time: 3:25pm – 4:30Ppm Eastern
URL:
Dial-In Number:
Access Code:

19. Thank you!
DRAFT: Not for distribution