RSNA Clinical Trials Software CTP 1 Clinical Trial

RSNA Clinical Trials Software CTP 1

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

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) 3

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

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

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

Standard Pipeline Stages: Import Services Dicom. Import. Service - Dicom Storage SCP Http. Import. Service - HTTP and HTTPS Polling. Http. Import. Service - HTTP for firewall penetration Directory. Import. Service - Manual import Archive. Import. Service - Bulk import 7

Standard Pipeline Stages: Processors Object. Logger IDMap Object. Tracker Dicom. Filter Xml. Filter Zip. Filter Dicom. Decompressor Dicom. Pixel. Anonymizer Dicom. Anonymizer Xml. Anonymizer Zip. Anonymizer - performance measurement - PHI ID lookup - data acquisition management - triage for Dicom. Objects - triage for Xml. Objects - triage for Zip. Objects - convert DICOM images - blank pixel regions - de-identify Dicom. Objects - de-identify Xml. Objects - de-identify Zip. Objects 8

Standard Pipeline Stages: Storage Services File. Storage. Service Indexed file management, with web access Basic. File. Storage. Service Indexed file management for NBIA 9

Standard Pipeline Stages: Export Services Dicom. Export. Service Http. Export. Service Polled. Http. Export. Service Ftp. Export. Service Database. Export. Service Sftp. Export. Service - DICOM Storage SCU - HTTP and HTTPS - HTTP for firewall penetration - FTP - External database interface - (implemented by U. Calgary) 10

File. Storage. Service 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 11

File. Storage. Service Viewer 12

Database. Export. Service Integrated queue management Database. Adapter Interface between Database. Export. Service and database itself Standard class to extend for a specific application 13

The HIPAA 18 (1 -9) 1. 2. 3. 4. 5. 6. 7. 8. 9. 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. ) Telephone numbers Fax numbers Electronic mail addresses Social security numbers Medical record numbers Health plan beneficiary numbers

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

De-identification 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

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

Dicom. Anonymizer 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 18

Database. Export. Service Integrated queue management Database. Adapter Interface between Database. Export. Service and database itself Standard class to extend for a specific application 19

CTP Example Data Acquisition Site CTP Dicom. Import. Service Dicom. Anonymizer Http. Export. Service … Principal Investigator Site CTP Http. Import. Service File. Storage. Service Database. Export. Service Dicom. Export. Service 20

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 21

The CTP Software Runs on Windows, Mac, Linux, Solaris Requires only Java and CTP are free MIRC/CTP Users Group meeting: Tuesday, 12/1 - 2: 30 - 4: 30 - Room N 128

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