A Good Practice-Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and...

Area of Science:

• Clinical research informatics
• Medical imaging in clinical trials
• Regulatory compliance in healthcare systems

Background:

• Increasing complexity and data volume in multicenter clinical trials necessitate robust imaging management.
• Existing Clinical Trial Imaging Management Systems (CTIMS) often lack comprehensive focus on regulatory compliance.
• The FDA guidance (2018) emphasizes appropriate medical imaging use aligned with Good Clinical Practice (GCP).

Purpose of the Study:

• To develop a comprehensive CTIMS that meets current regulatory guidelines and functional requirements.
• To ensure the developed CTIMS adheres to International Conference on Harmonization-GCP E6 and FDA regulations.
• To perform computerized system validation for regulatory compliance of the CTIMS.

Main Methods:

• Extracted key regulatory requirements from ICH-GCP E6, FDA 21 CFR 11 & 820, GAMP, and CDISC.
• Designed the system architecture with a multidisciplinary team, incorporating regulatory and clinical expertise.
• Conducted internal (V-model) and external computerized system validation.

Main Results:

• Developed AiCRO, a two-layer CTIMS (server and client systems) meeting regulatory and functional needs.
• Server system manages security, archive, backup, and audit trails; client system handles deidentification, transfer, viewing, QC, and electronic records.
• Internal and external validation confirmed AiCRO's adherence to all regulatory and functional requirements.

Conclusions:

• Successfully developed the AiCRO CTIMS, ensuring Good Practice compliance for managing clinical trial imaging data.
• The AiCRO system effectively addresses the complexity and data volume challenges in clinical trial imaging.
• Thorough validation demonstrates AiCRO's suitability for regulatory and functional demands in clinical trials.