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Clinical Trial Software

Clinical Trial Software

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Clinical Trial Software

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  1. Clinical Trial Software John Perry

  2. MIRC Overview – Teaching Files RSNA Clinical Trial and Research Software Hands On: Using the RSNA Teaching File RSNA 2011 MIRC Courses

  3. Internet HTTP / HTTPS Clinical Trial Dataflow X DICOM Database HTTP X DICOM X DICOM Data Acquisition Sites Principal Investigator Site

  4. Stand-alone application for clinical trials data: Processing and communication Simple installation and configuration: Single-click installation Single XML configuration file Configurable for: Data acquisition sites Principal investigator sites Platform-independent CTP

  5. Administrative functions Account management Status display Configuration display System properties display Script editors Authentication CTP Admin Web Server

  6. DicomObject Images SR / KOS / GSPS objects XmlObject Text data Flexible schema for identifiers ZipObject Encapsulation of trial-specific files Embedded manifest to carry the identifiers CTP Data Objects

  7. A pipeline is an ordered sequence of stages A stage is an element to perform a function: ImportService Processor StorageService ExportService Pipelines can have as many stages as necessary CTP supports multiple pipelines CTP Processing Pipelines

  8. DicomImportService - DICOM Storage SCP HttpImportService - HTTP and HTTPS PollingHttpImportService - HTTP for firewall penetration DirectoryImportService - manual submission ArchiveImportService - bulk import Standard ImportServices

  9. DicomFilter- triage for DicomObjects XmlFilter- triage for XmlObjects ZipFilter- triage for ZipObjects DicomAnonymizer- de-identify DicomObjects XmlAnonymizer - de-identify XmlObjects ZipAnonymizer - de-identify ZipObject manifests Standard Processors

  10. DicomDecompressor- convert DICOM images DicomTranscoder- convert DICOM images DicomPixelAnonymizer- blank pixel regions Standard Processors

  11. ObjectLogger - performance measurement ObjectCache - 21CFR11-compliant trials MemoryMonitor - operation monitoring IDMap - PHI ID lookup ObjectTracker - data acquisition management DatabaseVerifier - transfer confirmation between sites Standard Processors

  12. FileStorageService Indexed file management Web access with authentication BasicFileStorageService Indexed file management for the National Cancer Institute NBIA system DirectoryStorageService File management for the RSNA Image Sharing Project Standard StorageServices

  13. DicomExportService - DICOM Storage SCU HttpExportService - HTTP and HTTPS PolledHttpExportService - HTTP for firewall penetration FtpExportService - FTP DatabaseExportService - external database interface AimExportService - interface to AIM repositories Standard ExportServices

  14. Configurable tree structure Build-in web server Authentication Browse patients / studies / data objects Display images (tile / stack / series) Export data objects of all types Programmatic access via Ajax servlet FileStorageService

  15. FileStorageService Viewer

  16. Integrated queue management DatabaseAdapter Interface between the DatabaseExportService and the database itself Must be developed for each unique database schema Standard class to extend for a specific application DatabaseExportService

  17. AuditLog - 21CFR11-compliant trials MIRC - teaching files Standard Plugins Plugins add functionality beyond the scope of a single pipeline stage

  18. Name Location; all geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes. Dates (all dates related to the subject of the information, e.g. birth dates, admission dates, discharge dates, encounter dates, surgery dates, etc.) The HIPAA 18 (1-3)

  19. Telephone numbers Fax numbers Electronic mail addresses Social security numbers Medical record numbers Health plan beneficiary numbers The HIPAA 18 (4-9)

  20. Account numbers Certificate / license numbers Vehicle identifiers and serial numbers, including license plate numbers Device identifiers and serial numbers Web Uniform Resource Locators (URLs) Internet Protocol (IP) address numbers The HIPAA 18 (10-15)

  21. Biometric identifiers, including finger and voice prints Full face photographic images and any comparable images Any other unique identifying number, characteristic, or code The HIPAA 18 (16-18)

  22. Unnecessary PHI Removal Replacement with values that are the same for all patients Necessary PHI Replacement with values that allow subjects, studies, and images to be related to one-another, but that do not allow identification of the human being De-indentification

  23. Published in 2009 Defines de-identification profiles Basic Profile: most aggressive Several options for relaxing certain IDs This is a major contribution: it provides expert guidance for the de-identification of complex datasets DICOM Supplement 142

  24. Fully scriptable de-identification instructions DICOM Anonymizer Configurator Web UI for creating and editing scripts Support for DICOM Supplement 142 profiles Profile scripts written by Justin Kirby at NCI Support for user-defined profiles Default script: 142 Basic CTP DicomAnonymizer

  25. CTP DicomImportService DicomAnonymizer HttpExportService CTP Example Data Acquisition Site Modality … PACS Principal Investigator Site CTP HttpImportService FileStorageService DatabaseExportService DicomExportService Local Disk External Database Workstation

  26. Internet HTTP / HTTPS Firewall Penetration Principal Investigator Site DMZ CTP HttpImportService PolledHttpExportService DMZ Secure Network CTP PollingHttpImportService … (additional stages)

  27. Flexible All standard stages are highly configurable Extensible Interface-based structure Abstract classes for easy development of new stages Base class for developing database interfaces Adapting CTP

  28. Runs on Windows, Mac, Linux, Solaris Requires only Java Java and CTP are free MIRC/CTP Users Meeting: Monday, 11/28, from 3:00-4:15 in N128 CTP

  29. The MIRC Wiki http://mircwiki.rsna.org RSNA Forums http:forums.rsna.org User Comments, Questions, & Answers RSNA MIRC Software Announcements MIRC Implementers Corner Questions/Answers & Help

  30. RSNA MIRC Wiki