Your SlideShare is downloading. ×
0
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Image Data Capture in Clinical Trials
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Image Data Capture in Clinical Trials

1,124

Published on

These webinar slides address the challenges in clinical imaging trials and provide optimized software solutions for integrated and secure medical image data management.

These webinar slides address the challenges in clinical imaging trials and provide optimized software solutions for integrated and secure medical image data management.

Published in: Technology
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
1,124
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
14
Comments
0
Likes
1
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. Image Data Capture in Clinical Trials Co-hosted by: Dr. Marcus Bronzel, Director Image Core Lab, ABX-CRO Chris Wilke, Chief Technology Officer, DATATRAK
  • 2. The cloud-based global clinical research platform
  • 3. Strategy  and  Planning  Resource  Management   Study  Execu9on   Safety  Por6olio  Management  
  • 4. Improve organizational performanceLower total cost of ownershipEnsure regulatory compliance
  • 5. Agenda►  Challenges in Clinical Trials►  ABX-DIRECT •  Features •  Work Flow •  Modules •  Error Prevention •  Role Based Access •  Audit Trail •  Viewer►  Summary
  • 6. Challenges in Clinical Imaging Trials►  Multicentre clinical environment►  Requirements for Transfer of Image Data in clinical trials •  Data privacy (HIPAA) and Regulatory compliancy (21CFR- Part11)►  Workflow support for clinical trials►  Cost efficiency •  Easy to use, enroll, maintain, ….►  Complex and large data sets •  Meta Information (worksheets, transmittal forms)►  Support for using 3rd party viewing software
  • 7. ABX-DIRECT►  Optimized software solution for integrated and secure medical image data management►  Developed by leading image core lab together with safety and imaging experts specifically for multicenter clinical trials, clinics and hospitals
  • 8. ABX-DIRECT Features►  Advanced tool for multi-site longitudinal clinical imaging trials►  Repository and data transfer •  Image and eTF transfer incl. validation and de-identification of data►  Role based access control •  Administrator, quality controller, data manager, monitor & image senders►  Multi-format support►  Viewer independent •  Remote access to selected datasets for analysis by 3:rd party software►  Modular and open architecture •  Easy to integrate to other systems
  • 9. ABX-DIRECT Work Flow Remote sites / clinic Modality PACS Image sender Validation Anonymization Transfer Project Reader 1 Reader 2 Account admin Data manager QC Site 1 Sponsor Super admin Remote sites / reader Partner admin ABX-DIRECT server Expert Download Review Comment
  • 10. Send Client (DHN-S)•  Easy to install, powerful clients•  Distributed to remote sites•  Central configuration•  Manual upload / DICOM SCP•  Local validation of data•  Anonymization per profile/eTF•  Electronic signature•  Integrity validation of transfer•  Extensive log functionality 11
  • 11. electronic Transmittal Form (eTF)•  Transfers additional information coupled with DICOM data•  Pre-populated with information from DICOM data•  Writes information from eTF to DICOM header•  Basic input and plausibility checks (validation)•  Transfer only for registered image senders
  • 12. Download Client (DHN-QR)•  Downloads based on roles and access rights•  Automatic background synchronization with server•  Local DICOM Q/R for optimal flexibility•  Freedom to tailor own analysis / QC routines•  Use of current infrastructure Project Reader 1 Reader 2 Site 1 Sponsor https DCM Q/ RABX-DIRECT DHN-QR 3:rd part independent viewerserver Readers system
  • 13. Early Stage Error Prevention ►  Automation: minimize user decision ►  Information provided upon need ►  Direct validation of user input ►  Clear user interface, user guidance and feed-back ►  Project tailored eTF (configurable along the project) ►  Validation of entered information before sent ►  On the fly anonymization (project based) ►  Consistent information (eTF – Images) ►  eTF-image coupling guarantees data consistency“… most of the costly errors occurs when sending data, so we focused our efforts in error prevention …”
  • 14. Roles in Clinical Trials PA Roles and Responsibilities HTTPS QC ReviewImage sender: sends image + eTF accept / reject DM Readers rights HTTPS Logical distribution Expert readers: accesses images Image core lab
  • 15. Role Based Web Access Administrator / Data Manager Image sender Expert readerEach role has its own view
  • 16. Audit trail •  21 CFR Part 11 requires extensive audit trail –  Readable –  Transactional –  Who –  What –  WhenAudit trail view •  Separated from the main data base •  Filter / search
  • 17. Viewer Concepts / Alternatives Web based Remote access Local viewerDeployment efforts Easy Medium HighIT – infrastructure Medium Medium MediumSpeed Medium Medium HighNetwork Dependent Dependent IndependentFlexibility Low Medium HighAccessibility High Medium Low DataTrak Webinar 2012
  • 18. ABX-DIRECT Viewer Approach•  Simple web viewer –  Provide overview –  Quality Control•  Independent viewers –  Local installation (remote access possible) –  Download client (DHN-QR) •  Synchronized storage for background downloading •  DICOM-QR: provides access to data from
  • 19. Complete Solution with eCRFDistributionof DHN-S Clinic Image + eTF Reader Analysis Patient Analyzed DIRECT allocation Download image QC Access Rand # eTF /eCRF Accounts Status Status + Report R. & R. eTF Rand. Admin Patient eCRF enrollment Status Status Patient Start
  • 20. Summary•  Easy to use & cost effective –  Complete control over image intensive trials –  Image gathering and distribution to image readers –  Web based access and intuitive use –  Minimize / Detect errors at an early stage•  Upload module: –  data transfer with integrity check and validating eTF•  Central repository: –  Data storage and role based access control system•  Download module: –  Synchronize data for use with independent analysis software•  Regulatory Compliance –  21 CFR-Part 11 and HIPAA
  • 21. Improve organizational performanceLower total cost of ownershipEnsure regulatory compliance
  • 22. from Concept to Cure! with D ATATRAK ONE" DATAT R A K International Cleveland, Ohio Bryan, Texas Cary, North Carolina 888.677.DATA (3282) Toll Free www.datatrak.net

×