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

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 CTPCTP

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 FileStorageServiceFileStorageService

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 DatabaseExportServiceDatabaseExportService

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

18. 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 (1-3)

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

20. 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 (10-15)

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

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

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 CTPCTP

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