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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/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
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)
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
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
Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD)
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
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)
Privacy/Intellectual Capital Terms & Conditions Decision Tree – DSIC WS
Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD)
Next Steps • Summary of discussion points • Review of Action Items