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Planning/Monitoring Special Interest Group

Planning/Monitoring Special Interest Group. John Speakman Associate Director, Clinical Trials Products and Programs NCI Center for Biomedical Informatics and Information Technology john.speakman@nih.gov. caBIG™ Clinical Trials Management Systems Workspace Face-to-Face Meeting

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Planning/Monitoring Special Interest Group

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  1. Planning/MonitoringSpecial Interest Group John Speakman Associate Director, Clinical Trials Products and Programs NCI Center for Biomedical Informatics and Information Technology john.speakman@nih.gov caBIG™ Clinical Trials Management Systems Workspace Face-to-Face Meeting May 30 – 31, 2007 Portland, Oregon

  2. Agenda • Overview of Planning/Monitoring SIG Activities • Scope, Validation and Feedback • Study Initiation Tool (SIT) • DCP Enterprise System Knowledgebase (DESK) • Investigator and Site Credential Repository (ISC) • Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD) • Protocol Lifecycle Tracking (PLT) • Requirements Gathering for Data Sharing (after the break)

  3. What is the Clinical Trials Management Systems Workspace Trying to Achieve? • Facilitate the planning and instantiation of clinical trials, (and their monitoring of trials once they are instantiated) • Facilitate the conduct of clinical trials • Facilitate the reporting and sharing of clinical trial data to existing/new destinations, • Achieve interoperability • Increase the ability of systems to access and use the data and functionality of other systems • Facilitate the integration of new sources and destinations of data

  4. Special Interest Groups and Projects • Reporting/ • Sharing • Clinical Trials Database • Routine Data Exchange • Clinical Trials Object Model • Janus (FDA Repository) • Adverse Event Reporting and Collection • Conduct • Standardized Case Report Forms • Cancer Central Clinical Database (C3D) • Participant Registry • Laboratory Interface • Financial/Billing • Study Calendar • Subject Prescreening • Vendor Systems • Planning/ • Monitoring • Investigator and Site Credential Repository • Study Initiation Tool • Protocol Lifecycle Tracking • FIREBIRD • DCP/DESK • Interoperability • System Interoperability and Harmonization • Structured Protocol Representation (BRIDG) • Clinical Trials Interoperability Project

  5. Study Initiation Tool (SIT)

  6. DCP Enterprise System Knowledgebase (DESK)

  7. Investigator and Site Credential Repository (ISC)

  8. Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD)

  9. Protocol Lifecycle Tracking (PLT)

  10. Clinical Trial Process Map (Dilts et al.)

  11. Protocol Lifecycle Tracking Draft Storyboards • Enable non-technical domain people to model workflows • Standard building blocks of "IRB", "Contracts and Grants", etc. • Enable different groups of non-domain people to: • enter data about studies • move them along the workflows as milestones happen, e.g., when they receive the list of studies that got approved at IRB • Produce a dashboard that will answer questions like: • “How many studies are likely to start accruing patients in the next month (i.e., how many have passed the first n steps) • “Is the IRB a bottleneck?" (i.e., how many studies have passed the step before the IRB and are waiting, how many have been in this state for (e.g., )over two months?) • “Do we have any trials that are stuck in the system?" (i.e., are there any trials that have not changed state for (e.g.,) more than four months)? • Other questions? • Existing data sources exist (e.g., IRB database systems) • Ability to interoperate with these systems is desirable

  12. Requirements Gathering for Clinical Trial Data Sharing • Data Sharing in the Planning/Monitoring SIG • Data Sharing Opportunities and Potential Obstacles, other DSIC Considerations • Study Initiation Tool (SIT) • DCP Enterprise System Knowledgebase (DESK) • Investigator and Site Credential Repository (ISC) • Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD) • Protocol Lifecycle Tracking (PLT)

  13. Privacy/Intellectual Capital Terms & Conditions Decision Tree – DSIC WS

  14. Study Initiation Tool (SIT)

  15. DCP Enterprise System Knowledgebase (DESK)

  16. Investigator and Site Credential Repository (ISC)

  17. Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD)

  18. Protocol Lifecycle Tracking (PLT)

  19. Requirements Gathering for Clinical Trial Data Sharing

  20. Next Steps • Summary of discussion points • Review of Action Items

  21. Q & A

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