Image Data Capture in Clinical Trials
Co-hosted by: Dr. Marcus Bronzel, Director Image Core Lab, ABX-CRO
Chris Wilke, Chief Technology Officer, DATATRAK
The cloud-based global clinical research platform
Strategy and Planning
Resource Management
Safety
Por6olio Management
Study Execu9on
Improve organizational performance Lower total cost of ownership Ensure regulatory compliance
Agenda
► Challenges in Clinical Trials ► ABX-DIRECT • Features • Work Flow • Modules • Error Prevention • Role Based Access • Audit Trail • Viewer
► Summary
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
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
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
ABX-DIRECT Work Flow
Remote sites / reader
Modality PACS
Remote sites / clinic
Validation Anonymization Transfer
Image sender
Download Review Comment
Expert
Account admin Data manager QC Super admin Partner admin
Project
ABX-DIRECT server
Sponsor
Reader 1 Reader 2
Site 1
Send Client (DHN-S)
11
• 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
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
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
https DCM Q/R
3:rd part independent viewer DHN-QR Readers system
Project
ABX-DIRECT server
Sponsor
Reader 1 Reader 2
Site 1
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 …”
Roles in Clinical Trials
Image sender: sends image + eTF
Review accept / reject
Image core lab
QC
DM Readers rights Logical distribution
Roles and Responsibilities
PA
Expert readers: accesses images
HTTPS
HTTPS
Role Based Web Access
Each role has its own view
Administrator / Data Manager
Expert reader
Image sender
Audit trail
• 21 CFR Part 11 requires extensive audit trail – Readable – Transactional – Who – What – When
• Separated from the main data base • Filter / search
Audit trail view
Viewer Concepts / Alternatives
Web based Remote access Local viewer
Deployment efforts Easy Medium High
IT – infrastructure Medium Medium Medium
Speed Medium Medium High
Network Dependent Dependent Independent
Flexibility Low Medium High
Accessibility High Medium Low
DataTrak Webinar 2012
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
Complete Solution with eCRF
DIRECT
Start
Reader
Patient
Clinic
eCRF
eTF /eCRF Accounts R. & R. Rand. Admin
Distribution of DHN-S
Patient enrollment
Image + eTF
QC
Status
Status + eTF
Access
Patient allocation
Download
Analysis
Report
Status
Status
Analyzed image
Rand #
• 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
Summary
Improve organizational performance Lower total cost of ownership Ensure regulatory compliance
from Concept to Cure!with DATATRAK ONE"
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