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Clinical Trial Software Medical Imaging Resource Center John Perry RSNA 2010 MIRC Courses MIRC Overview RSNA Clinical Trial and Research Software Hands On: Using the RSNA Teaching File Clinical Trial Dataflow DICOM HTTP X Database Internet HTTP / HTTPS DICOM X DICOM X Data Acquisition Sites Principal Investigator Site CTP 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 Admin Web Server Administrative functions Account management Status display Configuration display System properties display Script editors Authentication CTP Data Objects 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 Processing Pipelines 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 Standard ImportServices DicomImportService HttpImportService PollingHttpImportService DirectoryImportService ArchiveImportService - DICOM Storage SCP - HTTP and HTTPS - HTTP for firewall penetration - manual submission - bulk import Standard Processors DicomFilter XmlFilter ZipFilter DicomDecompressor DicomPixelAnonymizer DicomAnonymizer XmlAnonymizer ZipAnonymizer - triage for DicomObjects - triage for XmlObjects - triage for ZipObjects - convert DICOM images - blank pixel regions - de-identify DicomObjects - de-identify XmlObjects - de-identify ZipObject manifests Standard Processors ObjectLogger MemoryMonitor IDMap ObjectTracker DatabaseVerifier - performance measurement - operation monitoring - PHI ID lookup - data acquisition management - transfer confirmation between sites Standard StorageServices FileStorageService Indexed file management Web access with authentication BasicFileStorageService Indexed file management for the National Cancer Institute NBIA system Standard ExportServices DicomExportService HttpExportService PolledHttpExportService FtpExportService DatabaseExportService - DICOM Storage SCU - HTTP and HTTPS - HTTP for firewall penetration - FTP - external database interface FileStorageService 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 Viewer DatabaseExportService 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 The HIPAA 18 (1-3) 1. Name 2. Location; all geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes. 3. 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 (4-9) 4. 5. 6. 7. 8. 9. Telephone numbers Fax numbers Electronic mail addresses Social security numbers Medical record numbers Health plan beneficiary numbers The HIPAA 18 (10-15) 10. Account numbers 11. Certificate / license numbers 12. Vehicle identifiers and serial numbers, including license plate numbers 13. Device identifiers and serial numbers 14. Web Uniform Resource Locators (URLs) 15. Internet Protocol (IP) address numbers The HIPAA 18 (16-18) 16. Biometric identifiers, including finger and voice prints 17. Full face photographic images and any comparable images 18. Any other unique identifying number, characteristic, or code De-indentification 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 DICOM Supplement 142 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 CTP DicomAnonymizer 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 Example Data Acquisition Site Modality PACS CTP DicomImportService DicomAnonymizer HttpExportService … Principal Investigator Site CTP External Database HttpImportService FileStorageService DatabaseExportService DicomExportService Local Disk Workstation Firewall Penetration Principal Investigator Site Internet HTTP / HTTPS DMZ CTP HttpImportService PolledHttpExportService DMZ Secure Network CTP PollingHttpImportService … (additional stages) Adapting CTP Flexible All standard stages are highly configurable Extensible Integrated class loader Interface-based structure Abstract classes for easy development of new stages Base class for developing database interfaces CTP Runs on Windows, Mac, Linux, Solaris Requires only Java Java and CTP are free MIRC/CTP Users Meeting: Monday, 12/29, from 3:00-4:15 in N127 Questions/Answers & Help The MIRC Wiki http://mircwiki.rsna.org RSNA Forums http:forums.rsna.org User Comments, Questions, & Answers RSNA MIRC Software Announcements MIRC Implementers Corner RSNA MIRC Wiki