1. 1 RSNA Clinical Trials Software CTP

2. FC DICOM FC DICOM PI DICOM Clinical Trial Dataflow Database HTTP Internet HTTP / HTTPS Data Acquisition Sites Principal Investigator Site

3. 3 CTP Stand-alone application for clinical trials data Processing and communication Simple installation Single click installation Single XML configuration file Configurable for: Data acquisition sites Principal investigator sites Platform-independent (Java 1.6)

4. 4 Admin Web Server Administration functions Account management Status display Configuration display System properties display Script editors Authentication

5. 5 CTP Data Objects DicomObject Images SR / KOS / GSPS objects XmlObject Text data Flexible schema for identifiers ZipObject Encapsulation of trial-specific files Embedded manifest.xml file to carry the identifiers

6. 6 Processing Pipelines CTP supports multiple pipelines Each pipeline consists of a sequence of stages ImportService Processor StorageService ExportService Stages can appear in almost any order Pipelines can be as long or short as required

7. 7 Standard Pipeline Stages: Import Services DicomImportService- Dicom Storage SCP HttpImportService- HTTP and HTTPS PollingHttpImportService- HTTP for firewall penetration DirectoryImportService- Manual import ArchiveImportService- Bulk import

8. 8 Standard Pipeline Stages: Processors ObjectLogger- performance measurement IDMap- PHI ID lookup ObjectTracker- data acquisition management DicomFilter- triage for DicomObjects XmlFilter- triage for XmlObjects ZipFilter- triage for ZipObjects DicomDecompressor- convert DICOM images DicomPixelAnonymizer- blank pixel regions DicomAnonymizer- de-identify DicomObjects XmlAnonymizer- de-identify XmlObjects ZipAnonymizer- de-identify ZipObjects

9. 9 Standard Pipeline Stages: Storage Services FileStorageService Indexed file management, with web access BasicFileStorageService Indexed file management for NBIA

10. 10 Standard Pipeline Stages: Export Services DicomExportService- DICOM Storage SCU HttpExportService- HTTP and HTTPS PolledHttpExportService- HTTP for firewall penetration FtpExportService- FTP DatabaseExportService- External database interface SftpExportService- (implemented by U. Calgary)

11. 11 FileStorageService Configurable tree structure Built-in web server Authentication mechanism Browse patients / studies / data objects Display images (tile / stack / series) Export data objects of all types Programmatic access via Ajax servlet

12. 12 FileStorageService Viewer

13. 13 DatabaseExportService Integrated queue management DatabaseAdapter Interface between DatabaseExportService and database itself Standard class to extend for a specific application

14. The HIPAA 18 (1-9) 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.) 4.Telephone numbers 5.Fax numbers 6.Electronic mail addresses 7.Social security numbers 8.Medical record numbers 9.Health plan beneficiary numbers

15. The HIPAA 18 (10-18) 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 Universal Resource Locators (URLs) 15.Internet Protocol (IP) address numbers 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

16. 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 distinguished, but that do not allow identification of the patient De-identification

17. 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

18. 18 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

19. 19 DatabaseExportService Integrated queue management DatabaseAdapter Interface between DatabaseExportService and database itself Standard class to extend for a specific application

20. 20 CTP Example CTP DicomImportService DicomAnonymizer HttpExportService Data Acquisition Site CTP HttpImportService FileStorageService DatabaseExportService DicomExportService Principal Investigator Site …

21. 21 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

22. The CTP Software Runs on Windows, Mac, Linux, Solaris Requires only Java Java and CTP are free MIRC/CTP Users Group meeting: Tuesday, 12/1 - 2:30 - 4:30 - Room N128

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