Clinical Research Data Capture Fields

Proposed Profile: Clinical Research Data Capture Fields

• Proposal Editor: Landen Bain, CDISC Liaison to Healthcare
• Editors: Rhonda Facile, CDASH Manager for CDISC; Gary Walker, Assoc. Dir Programming Standards, Quintiles; Bron Kisler, Terminology Manager, CDISC
• Date: January 2008
• Version: 1.0
• Domain: Patient Care Coordination

Summary

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<Summarize in one or two lines the existing problem . E.g. "It is difficult to monitor radiation dose for individual patients and almost impossible to assemble and compare such statistics for a site or a population.">

<Demonstrate in a line or two that the key integration features are available in existing standards. E.g. "DICOM has an SR format for radiation dose events and a protocol for exchanging them.">

<Summarize in a few lines how the problem could be solved. E.g. "A Radiation Dose profile could require compliant radiating devices to produce such reports and could define transactions to actors that collect, analyze and present such information.">

<Summarize in a line or two market interest & available resources. E.g. "Euratom and ACR have published guidelines requiring/encouraging dose tracking. Individuals from SFR are willing to participate in Profile development.">

<Summarize in a line or two why IHE would be a good venue to solve the problem. E.g. "The main challenges are dealing with the chicken-and-egg problem and avoiding inconsistent implementations.">

The Problem

While RFD simplifies data capture for investigator sites, content profiles will extend its value.

The successful demonstration of the IHE ITI integration profile Retrieve Form for Data-capture (RFD) has dramatically increased the level of interest expressed by multiple stakeholders across the healthcare value chain. Of these stakeholders, Electronic Health Record (EHR) vendors in particular are seeking to leverage RFD and the domain experience of CDISC to enable more efficient workflow when conducting clinical research within an EHR session.

The current implementation of RFD creates a data export template within an EHR session by importing a Case Report Form (CRF) from the appropriate clinical research system (Forms Manager). While the benefits of RFD have inspired the need for tighter integration, the lack of content profiles that complement RFD forces the EHR vendors to develop custom scripts to auto-populate relevant data available in the EHR into the CRF. The proposed content profile will align the data requirements of the RFD data export template with CDISC’s Clinical Data Acquisition Standards Harmonization (CDASH) effort to standardize the content of the case report form. This multi-organizational effort, endorsed by FDA, will complete version 1.0 in first quarter 2008.

This content profile will also complement the Query for Existing Data profile currently in development. A CDASH-based content profile would provide the list of data elements that an EHR should have on hand to respond to an external query from a clinical research system.

Key Use Case

The point of departure for this use case is a patient care site where clinical research is underway, and where RFD is already implemented. The ‘before’ state shows the use of RFD without a content profile. The ‘after’ state describes the use of RFD in concert with the proposed content profile.

Before Clinical Research Data Capture (but after RFD):

A patient arrives for a visit as scheduled in the clinical trial protocol. The "study coordinator" (research nurse or clinical research coordinator) responsible for collecting clinical research data during the patient encounter, initiates an EHR session which invokes the Form Filler actor of RFD to retrieve the appropriate clinical trial CRF from the clinical research system (Form Manager). Scripts executed from within the EHR retrieve standard demographic data, but not vital signs or other necessary study-specific data which are available in the EHR. The study coordinator completes the case report form by transcribing vital signs and concomitant medication data from other screens in the EHR.

After Clinical Research Data Capture working in concert with RFD:

A patient arrives for a visit as scheduled in the clinical trial protocol. The "study coordinator" (research nurse or clinical research coordinator) responsible for collecting clinical research data during the patient encounter, initiates an EHR session which utilizes RFD to retrieve the appropriate clinical trial CRF. The EHR identifies available CDASH data and auto-populates the retrieved form with standard demographic data, vital sign data and concomitant medication data. The study coordinator reviews the auto-populated data in the retrieved CRF, and submits the data back to the clinical research system (Forms Receiver).

Standards & Systems

Systems

• Electronic Health Records(EHR); Electronic Medical Records (EMR)
• Electronic Data Capture (EDC) systems;
• Clinical Data Management Systems (CDMS);
• Data Archiving systems;
• Biopharmaceutical sponsor protocol systems.

Standards

• CDISC standards and guidances:
  • Operational Data Model (ODM);
  • http://cdisc.org/standards/cdash/index.html Clinical Data Acquisition Standards Harmonization (CDASH)]
  • Submission Data Tabulation Model (SDTM);
  • Standard code sets from CDISC's terminology project;
  • Electronic Source Document Initiative (eSDI).
• IHE profiles:
  • Retrieve Form for Data-capture (RFD);
  • Query for Existing Data (QED)
  • W3C standards: XForm

  Technical Approach

  The Clinical Research content profile can be used with either RFD or QED, the essential difference between these two approaches being the existence or lack of a data capture form. A third technical approach uses both RFD and QED, where QED handles the autopopulation of a data capture form that subsequently gets displayed by the RFD FormFiller actor.

  Clinical Research content profile working with RFD

  The Clinical Research content profile publishes the data elements that are common to all Case Report Forms (CRFs), as defined in CDISC's CDASH specification. CDASH will be further extended using code lists from CDISC terminology project, and data element definitions from CDISC's SDTM. An EHR can use the specification to populate an XML document that accompanies the RetrieveForm transaction, sent by FormFiller to FormManager. The RFD FormManager extracts the data elements and pre-populates the form that is returned to the FormFiller.

  Clinical Research content profile working with QED

  The Clinical Research content profile can augment QED in one of two ways. Based on the terminology specified in the content profile, a QED Clinical Data Consumer can issue a query to the QED repositories, mapping between the Clinical Research profile and the existing QED specifications. Alternatively, a new QED repository could be build based on the Clinical Research profile. In this case, a clinical research based QED Clinical Data Consumer can obtain data from the QED repository with no mapping.

  Clinical Research content profile with both RFD and QED

  A third approach uses QED to pre-populate a form that then gets displayed by the FormFiller. In this case, the RFD FormManger acts as the QED Clinical Data Consumer and obtains the CRF data elements from the appropriate QED repository. The data are bound to the data capture form which is provided to the FormFiller on the FormRetrieve transaction.

  Existing actors

  RFD FormFiller, FormManager, FormReceiver, FormArchiver

  New actors

  QED Repositories

  Existing transactions

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  New transactions (standards used)

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  Impact on existing integration profiles

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  New integration profiles needed

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  Breakdown of tasks that need to be accomplished

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  Support & Resources

  Development of the Clinical Research content profile has gained enthusiastic support from groups within CDISC, primarily the CDASH team. CDASH, in turn, links to sixteen organizations within the clinical research industry, and has strong support from FDA. The CDASH Program Manager, Rhonda Facile, has agreed to serve as editor for the Clinical Research content profile. Gary Walker, Quintiles, a CDASH team member and project manager of the Eli Lilly/Cerner/Quintiles trial implementation of RFD, will also serve as editor.

  The CDISC Terminology project also lines up behind the Clinical Research content profile. Bron Kisler, Terminology Program Manager, has agreed to serve as the third editor.

  Risks

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  Open Issues

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  Tech Cmte Evaluation

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  Effort Evaluation (as a % of Tech Cmte Bandwidth):

  • 35% for ...

  Responses to Issues:

  See italics in Risk and Open Issue sections

  Candidate Editor:

  TBA

  5. Discussion

  IHE has successfully reached the biopharmaceutical industry through a content-free integration profile, RFD. Extending the reach of RFD by binding it to clinical research specific content profiles further reinforces this cross-industry alliance. Benefits achieved will result in greater efficiencies between clinical trial sponsors, investigators and research sites, facilitating data capture and improving data quality.