Streamlining the Flow of Clinical Trial Data: EHR to EDC to Sponsor

Transcription

1 Streamlining the Flow of Clinical Trial : EHR to EDC to Sponsor Landen Bain Liaison to Healthcare CDISC Interchange Standards Consortium) Jane Griffin, RPh Director, Pharmaceutical Research Cerner Corporation Secondary Use of EHR Research Quality Drug Safety Clinical Research Disease Registry Public Health Secondary Use Primary Use EHR Electronic Health Records Care Givers

2 Clinical Trial Scenario Clinical Trial Workflow Lilly S00 Protocol Archive Get CDASH Retrieve Form by FormID and Pass the Archive URL and the Pre-Populated CDASH Pre-Populated Form Viewed within the Workflow Submit Quintiles Receipt/ Retrieve (ex. Running AEs) Disease Registry Scenario

3 Disease Registry Workflow Greenway Allscripts ArchiveFor m IBM Submit Form Retriev e Form XForm s XForm s Formedix Form Supplier Form Supplier IHE Interoperability Showcase Clinical Trial Scenario: utilizing the RFD (Retrieve Form for Capture) Profile to streamline the flow of clinical trial data from the clinical site to the sponsor Scenario Stakeholders (RFD Actor Role): = Trial Sponsor = EHR system at a clinical trial site () = CRO responsible for data aggregation and data management using data management system () = Repository for the forms () and the site s clinical trial data () Overview Current State: What are we trying to fix? 007 (Year ) RFD Demonstration Highlights 008 (Year ) RFD Progress System Flows: Initial data submission clarifications RFD Value Statements

4 Current state: what are we trying to fix? Tremendous burden of clinical research processes falls on clinical research coordinators at sites Protection of research subjects Compliance with regulatory requirements Communication/interactions with multiple sponsors Precise and accurate documentation transcription from source to CRF (again and again and again) Silo d systems and workflows for research and healthcare Multiple computer system user interfaces for clinical trial data entry with no standardization: unique logins, different data from trial to trial, different data formats, etc. transcription impacts efficiency and data quality transcription introduces opportunity for transcription errors Transcription and source data verification processes are time-intensive RFD 007: st year accomplishments The Value: What Did We All Gain Demonstrated the concept of Interoperability between EHR and EDC systems and the data exchanged Confirmed a potential process using the RFD profile and associated standards Collaborated on issues and potential resolutions Identified the hurdles RFD 008: Significant Progress Standardization: Utilized draft CDASH data standards currently being defined by CDISC Utilized CDISC metadata for data exchange and archive Mapping: Mapped CDASH data elements back to the EHR as the standard set of EHR data elements that are also relevant to research Pre-population: Pre-populated the ecrf with the CDASH data elements for display, review, revision, and verification prior to submission Clarification Process: Extended the RFD profile to include the data clarification process and defined a logical workflow Validation: Passed Connectathon interoperability testing

5 Clinical Trial RFD System Flow Archive Get CDASH Pre-Populated Form Viewed within the Workflow Retrieve Form by FormID and Pass the Archive URL and the Pre-Populated CDASH Submit Retrieve (e.g. Running AEs) Receipt/ IP L Quintiles Clinical Trial Clarifications RFD System Flow Archive 7 Request to Retrieve Clarifications by Site ID and Pass the Archive URL Clarifications Form Viewed within the Workflow Submit Retrieve Outstanding Clarifications Receipt/ IP L Clear Clarification Flags Raise Clarification Flags Quintiles Defining the Value of RFD Flexible RFD will accommodate different site functionality (manual data entry to hybrid to fully electronic environments) User Friendly Minimizes data transcription Integrates research into the EHR workflow Utilizes standard process across sponsors/studies Efficient Minimizes data transcription Leverages existing EHR systems at sites Changes the focus of site monitoring RFD has the potential to be disruptive as well as transformational to clinical research.