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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