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Overview of CTEP-ESYS

CTEP Enterprise System Integration Roadmap Steve Friedman, Chief CTOIB CTMS Steering Committee October 19, 2010. Overview of CTEP-ESYS. CTEP-ESYS - 22 application system which supports the development and monitoring of CTEP sponsored trials CTEP-ESYS application use started in 1998.

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Overview of CTEP-ESYS

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  1. CTEP Enterprise System Integration RoadmapSteve Friedman, Chief CTOIBCTMS Steering CommitteeOctober 19, 2010

  2. Overview of CTEP-ESYS • CTEP-ESYS - 22 application system which supports the development and monitoring of CTEP sponsored trials • CTEP-ESYS application use started in 1998. • Contains information on more than: • 13,000 active trials • 850,000 patients • 800 INDs • 10,000 sites • 36,000 investigators • Moderate FISMA risk • Major IT investment ranked by OMB (Ranked 4th out of 651 in HHS) • The governance team reviews all new development and enhancements to CTEP-ESYS • IT Contract (7 years Feb. 2009 – Jan. 2016) includes tasks to achieve harmonization with caBIG™, CTRP, and CTSU

  3. External Applications CTEP Business Enterprise Overview of CTEP-ESYS AdEERS CDUS CES ABS CAEPRS CIBISCIT Reading Room IR CTMB-AIS IAM ECM/ AMM CTMB-AIS CDUS Reports EQW FIATS OAOP Safety Profiler OAOP Timeline Reports DARTS PATS RABITS SMARTS EMS Enterprise Services AdEERS Web-Service Organization Service IAM Authentication Person Service Protocol Search CTEP Enterprise Database (CTEP-ESYS) Metalayer CTEP Enterprise Search & Reporting

  4. Summary of Integration Activities • CTEP-ESYS, CTEP PIO, and CTSU (RSS) with CTRP • caAERS-AdEERS migration including AdEERS web service • NES-CES • IAM-RAVE security layer enhancement • eCRF implementation • eCTD integration • ePA evaluation, selection, implementation • SOA migration

  5. Integration with CTRP • Development of organization, person and protocol services (CES-NES integration) • PIO sends approvals, study status updates, and IRB approvals to CTRO for non-Group studies • Internal integration with CTSU to address study status changes, Group roster management and IRB information collection (through RSS for Groups) • CTOIB developed spreadsheet containing all protocol information in CTEP-ESYS and forwarded to CTRO to facilitate abstraction in CTRP • Currently reviewing DCP protocol service for use by CTEP

  6. caAERS-AdEERS Migration • CTEP review of caAERS by key stakeholders • IDB and TRI assessment and processing of submitted tickets • Use of AdEERS web service • Need to keep caAERS and CTEP-ESYS in sync to enforce protocol language elements

  7. CES-NES Integration • Organization repository (extension of ECM) developed jointly by CBIIT-CTEP in 2009 • Development of ECM web service • CTRO curates one level of organizations, CTEP curates another level • Need to have single source of truth without any data transmission disruption • Revising model – considerations include curation based on request point of entry, duplication in repository and how an organization is defined • Intended development is to complete organization then person then protocol • Currently evaluating the DCP protocol service module soon to be deployed to see if it can be leveraged for this effort

  8. CTSU Integration Activities

  9. CTSU Integration Activities • Integration of IAM with CTSU enterprise • All the applications within the CTSU enterprise (RSS, OPEN, CTSU website, Oracle clinical and CDIMS) have been integrated with IAM authentication systems. • Group systems are integrated with IAM system via CTSU enterprise web services. • Synchronization of protocol statuses between Regulatory Support System (RSS)and CTEPESYS • Single point of status maintenance for the Cooperative Group users. • Groups will be maintaining the protocol statuses in RSS. RSS will send status change transactions to CTEPESYS. • CTMB Roster integration • Single point of institution roster maintenance for the Cooperative Group users. • Rosters change requests (addition and updates) transactions are sent from RSS to CTEPESYS

  10. CTSU Integration Activities • Coordination for standardization of CTEP Institution code assignment and updates to institution codes • Development of standard institution code definition • Standardize and streamline code update process • Address change, closures, mergers and splits • Provide venue to discuss institution code disputes • IRB approval/person role transactions for P2C studies to facilitate drug shipments to investigators • RSS collects IRB approvals for the P2C studies. • The participating investigator information is maintained in RSS. • IRB approval and investigator data is sent in real time to CTEPESYS • Submission of IRB approval data to CTRP • CTSU is working with CTRP to submit the incremental IRB approval data to CTRP through NCI Enterprise Services (NES)

  11. Other Integration Projects • IAM-RAVE security enhancement • Updating IAM as authentication tool for RAVE users accessing iMedidata for CTEP-sponsored studies. Two phase project: • Authentication with anticipated January 2011 completion • Authorization (TBD, post phase 1 completion) • eIND submission • Implementing Liquent tool for two phase project. 1st: submit FDA packets electronically. 2nd: eIND submission with integration of tool into CTEP-ESYS (RABITS) • ePA evaluation • CTEP led working group assessing requirements and products leading to procurement and implementation of ePA tool

  12. Other Integration Projects • eCRF • Conducting analysis of round 1 and 2 approved eCRFs to assess changes required of CTEP-ESYS • Need ‘critical mass’ to minimize costs to system changes • 11G migration • Server upgrade required due to change in service provide by Oracle • SOA development • IT plan includes migration of all applications to SOA starting with ‘high-impact’ applications (PATS, DARTS, RABITS, etc) • OAOP, now deployed, first CTEP-ESYS application using SOA

  13. Projects with Integration Potential to the PLT Dashboard • Timelines Report secure site • Developed by CTEP in response to OEWG recommendations • Deployed July 2010 • Utilizes protocol and milestone information contained within the CTEP-ESYS • IPAD • Replaces EQW, CQW, and EIS • Plan for deployment is November 2010 • Designed to be an internal query tool • Dashboard capability • Additional potential for integration with CTRP and OPEN

  14. Acronyms • AdEERS – Adverse Event Expedited Reporting System • caAERS – Cancer Adverse Event Reporting System • caBIG™ - Cancer Biomedical Informatics Grid • CDUS – Clinical Data Update System • CES – CTEP Enterprise Services • CQW – CIBISCIT Query Wizard • CTEP-ESYS – Cancer Therapy Evaluation Program Enterprise System • CTMB-AIS – Clinical Trials Monitoring Branch Audit Information System • CTOIB – Clinical Trials Operations and Informatics Branch • CTRO – Clinical Trials Reporting Office • CTRP – Clinical Trials Reporting Program • CTSU – Cancer Trials Support Unit • DARTS – Drug Authorization and Review Tracking System

  15. Acronyms • DCP – Division of Cancer Prevention • eCRF – Electronic Case Report Form • eCTD – Electronic Common Technical Document • ECM – Enterprise Core Module • eIND – Electronic IND • EIS – Enterprise Information Service • ePA – Electronic Protocol Authoring • EQW – Enterprise Query Wizard • FIREBIRD – Federal Investigator Registry of Biomedical Informatics Research Data • FISMA – Federal Information Security and Management Act

  16. Acronyms • IAM – Identity and Access Management • IPAD – Integrated Platform for Agents and Diseases • IR – Investigator Registration • NES – NCI Enterprise Services • OAOP – Online Agent Ordering and Processing • OMB – Office of Management and Budget • PATS – Protocol Authorization and Tracking System • PIO – Protocol and Information Office • RABITS – Regulatory Affairs Branch Information Tracking System • RSS – Regulatory Support System • SOA – Service Oriented Architecture

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