Clinical Trials

Clinical trials involving medical imaging require careful handling of DICOM data to protect patient privacy while maintaining data integrity for regulatory submission. This guide covers how to implement DICOM anonymization for clinical trials using Aspose.Medical for .NET, including subject ID mapping, audit trails, and multi-site coordination. Clinical Trial Anonymization Requirements Anonymizing DICOM files for clinical trials differs from standard de-identification. Regulatory bodies like the FDA require: Consistent subject identifiers: Each patient must receive a unique trial subject ID that remains consistent across all imaging sessions Audit trails: Complete documentation of what was anonymized and when Data integrity: Medical image quality must be preserved exactly Reproducibility: The same input must produce the same anonymized output 21 CFR Part 11 compliance: Electronic records must meet FDA requirements for authenticity and integrity Setting Up the Anonymization Framework Start by creating a clinical trial anonymization service that handles subject mapping and audit logging: ...