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Published on: October 3, 2019
Regulatory compliance requirements for an open source electronic image trial management system
Colin Rhodes1, Steve Moore, Ken Clark
1VirtualScopics Inc., Rochester, NY 14625, USA. Colin_Rhodes@virtualscopics.com
Summary
Managing imaging in clinical trials requires regulatory compliance. This study defines a software architecture and development process for tracking significant data changes, aiding drug development.
Area of Science:
- Biomedical Informatics
- Clinical Trial Management
- Regulatory Science
Background:
- Global need for efficient clinical trial software to accelerate research and drug development.
- Regulatory requirements, including software development controls and data provenance, are critical for U.S. Food and Drug Administration (FDA) compliance.
- A significant challenge is identifying critical data changes within image-based clinical trial workflows.
Purpose of the Study:
- To address the need for regulatory-compliant software in imaging-based clinical trials.
- To investigate provenance tracking requirements for managing data changes in clinical trials.
- To define a software architecture and development process that meets FDA regulations.
Main Methods:
- Studied provenance tracking requirements specific to image trial management.
- Defined a software architecture utilizing open-source components.
- Established a software development process adhering to U.S. regulatory standards.
Main Results:
- Identified key requirements for provenance tracking in imaging clinical trials.
- Proposed a novel software architecture designed for regulatory compliance.
- Developed a software development process incorporating open-source solutions.
Conclusions:
- The defined architecture and development process meet U.S. regulatory requirements for imaging clinical trials.
- The approach facilitates significant data change identification, crucial for drug development.
- Open-source software components can be effectively utilized in regulatory-compliant clinical trial management systems.
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