8/27/2014. Office of Research Informatics(ORI) CORI. Introduction- The Office of Research Informatics (ORI)?

Transcription

1 Office of Research Informatics(ORI) Project Updates and New Initiatives Research Wednesday August 27th, 2014 Cory Ennis Julie Eckstrand Eric Hall Tony Leiro Introduction- The (ORI)? Product Updates- CTMS update Julie Eckstrand LabVantage Biobank Eric Hall (Product Manager) Tony Leiro (Product Manager) The Office Clinical of Office Research of Research Informatics? Informatics? CORI Better Acronym IMO Mission: ORI provides quality support services to develop, implement, operate and manage Duke's research programs, products and applications. 1

2 The Who are we? Iain Sanderson CRIO Vice Dean Financial Manager Mitchelle Carmon STEVE WOODY Portfolio Management (financial and resource planning, architecture) Product managers CORY ENNIS Asst. Dean for IT Operations Application support group PAULA MORRISON Asst. Dean for Research Software Development Software Development group TONY LEIRO Analyst and business development How do we implement and support our products? Governance Application User Group Business owner Product Manager ORI Implementation Application Support ( Tier 2,3 support) application analysts Change Management Reporting Training (with DHTS) Utilizes DHTS Enterprise Service Desk (Tier 1 support) Infrastructure and Hardware support Catalog of Programs eirb CTMS ( eresearch ) Research workflow in Maestro REDCap database provision Conflict of Interest (COI) Grants.Duke Sponsored Projects System Vivarium/Laboratory Animal management system IACUC (animal IRB) system Biorepository (LabVantage) The The Shared Services application, Storefront and cores management (LabVantage) Analytics Workspace for Research 2

3 Catalog of Programs (Continued) Optimization of Maestro for Research BPA s RFD MyChart Investigator Portal, MyResearchHome@Duke The Data Governance and Stewardship Program Research self service ( DEDUCE, i2b2 and SHRINE) Enhanced use of the Data warehouse for research ( Marts, deidentification, data requests) Data management for research Research navigation support, MyResearchTeam@Duke The Common Services Application (SPARC) Scholars@Duke research networking (VIVO) The current status of all ORI opportunities, projects and products may be viewed on the ORI wiki: eirb Status and Plans Vended system (Click Commerce) User friendly user interface Challenging for IT to support Has been stabilized Factors in plans for system: eirb has become de facto home for approvals/training/system information econsent Synergy between systems Clinical Trials Management System (CTMS) Julie Eckstrand July 2014 Duke University Health System 3

4 Duke Office of Clinical Research Epic: Clinical Research workflow Clinical Studies, Subjects, Research Charges, MyChart, BPAs RFD SAP: FCs EDC: REDCap RFD Click eirb Studies, Named Personnel Daily Export Studies, Subjects, Charges EDW/ Research Management Data Mart: All Velos data, All Epic data, All eirb data, All Reporting, (NCI reporting) Duke s Clinical Research Systems Custom Interface Velos eresearch: CTMS All clinical and nonclinical study registry, All subjects registry, Volunteer registry, Sample tracking, Invoicing, AE Management, Financial mgt ETL Vision To complement and enhance functionality already in Maestro research To provide technology solution(s) that help the research community: Do their work (efficiency) Monitor their work (productivity, compliance) Report on their work (metrics, aggregation) Opportunities/Challenges Governance: representative of key stakeholders Defining and prioritizing the needs of the community: Participation of Subject Matter Experts Promotion of Consistent business processes Filling gaps not met in Maestro Research Implementing technology based paths that will: Move data to where is needs to be (interfaces) Be workflow-oriented Include actionable alerts and notifications Provide access to compiled information/reports with robust filters 4

5 Eric R. Hall Product Manager Medical Center Executive Committee 8/12/14 Vision To create an enterprise-wide system for managing the biospecimen collections throughout Duke that is stable, scalable and supportable. LabVantage for biobanking will support and enhance the research portfolio at Duke by offering a common infrastructure and point of access for well curated biospecimens which are critical for many areas of basic and clinical research and provide 14 What Does This Mean for Duke Better tracking of biospecimens and greater adherence to good biobanking practice Centralized data location for physically dispersed collections Greater exposure for available specimens through Duke Index of Biospecimens Reduced operating costs Infrastructure designed with accreditation in mind Data handling capabilities that align with NIH grant expectations 15 5

6 Implementation Timeline FY2015 Finalize sample management FRS, receive 2 functional builds Provide data migration schema and 10% data set to LV Receive remainder of core functionality and first bank specific functionality Re-engage with DNA bank for requirements Begin requirements gathering for 1 st phase II bank (BRPC) Testing for 1 st Phase II bank (BRPC) Receive two major functional builds plus bug fixes Receive 1 functional build and bug fixes Receive IGSP data migration tools Begin requirements for 2 nd phase II bank Begin requirements for 3 rd phase II bank Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Requirements, Development, Testing, Training (Phase I) CAGPM Go Live DNA Go Live Received first functional build on 8/5/14, currently in testing 16 Proposed Template Future Banks Bank #1 Bank #2 Bank #3 Duke LV Duke LV Duke LV wk 1 wk 2 wk 3 wk 4 wk 5 wk 6 wk 7 wk 8 wk 9 wk 10 wk 11 wk 12 wk 13 wk 14 wk 15 wk 16 Gather User Stories FRS Development Testing and Training Tech Requirements Development and Data migration Gather User Stories FRS Development Tech Requirements Development --> Gather User Stories FRS Development * Development time is an estimate and is dependent on the complexity of the requirements, but should decrease for later banks as more functionality is available We are currently quoting a cycle time of weeks 17 August 12,

7 Vision Create the single source of truth for reporting of research administration information across Duke Medicine Integrate data from base operational systems such as SPS, eirb, Maestro, Scholars, CTMS, and others to present a complete view of research projects Enable the ability to report information across project attributes such as sponsors, investigator, funding types, number of subjects enrolled etc. Create reports, dashboards, web services and apps from the data mart intended to assist in the management of individual projects as well as the CRU s and Department s overall research portfolio Ensure a solid foundation by leveraging existing architecture of the Enterprise Data Warehouse to build the RMDM 19 RMDM Architecture IRB Contracts eresearch CTMS Sponsored Projects System SAP Financial Data Licensing Data t Reports and Dashboards Duke Elements Scholars@Duke SPARC EPIC Other Duke Systems 20 Current Phase I CTSA Site Based Metrics Study Dimensions Sponsor Principal Investigator Sub-Investigators CRU Study Coordinator Investigator-initiated or sponsor-initiated Single site or multi site study Observational or interventional From Submission to Contracts Office Duke Contract Execution IRB Approval PI Submit CRU Approval Study Startup Time Institutional Approval Study Participant Dimensions Contracted /Anticipated Actual Enrolled participants (Bill Risk) Duke patient Demographics Sex, Race, Age, Location To Duke Execution Full Execution with Sponsor Institutional Approval CRU Approval IRB Approval First Enrolled 21 7

8 Implementation Timeline Initial Load of DCRI (Coordinated Trial ) Metrics Migrate Raw Data Build out BO from Data Sources Load anticipated Universe and POC enrollments and nonbill risk actual Reports enrollments Report/Dashboard Design Mart Design and Structure and DCRI Report Development Create ETL Loads Integration Begin requirements gathering for next phase (Scholars, Elements, SPS?) for project output measurements Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Phase I Go Live Site Based Research Metrics (Phase I) Phase I Rollout to Departments, Centers and Institutes Fiscal Year Thank you! Cory Ennis Assistant Dean for Information Technology (ORI) Julie Eckstrand Product Manager (ORI) Eric Hall Product Manager (ORI) Tony Leiro Product Manager/Business Development (ORI) 8