ISO 18323:2016 is titled:
“Health informatics — Requirements for structure, content and semantics of clinical study reports”
It specifies the requirements for structuring and semantically encoding clinical study reports (CSRs), enabling effective electronic exchange and processing. This includes guidance on terminology use, data elements, and metadata to ensure clarity, consistency, and regulatory compliance.
The standard facilitates improved data sharing, analysis, and reporting in clinical trials and healthcare research.
Clinical study reports are critical documents for evaluating the safety and efficacy of medical interventions. Without standardized structure and terminology:
ISO 18323 addresses these challenges by providing a consistent framework that supports interoperability and transparency in clinical data management.
Implementing ISO 18323 delivers:
📄 Standardized Clinical Study Reports
Enhances clarity and completeness of study documentation.
🔗 Improved Data Interoperability
Facilitates seamless exchange between healthcare and research systems.
🛡️ Regulatory Compliance Support
Aligns with requirements of bodies like FDA, EMA, and ICH.
📊 Enhanced Data Quality and Analysis
Enables accurate aggregation and meta-analysis.
🌍 Facilitates Global Collaboration
Supports multinational clinical trials and data sharing.
With Growth Management Corporation’s ISO 18323 consulting, your organization gains:
✅ Efficient Clinical Data Management
Streamline CSR creation and exchange processes.
✅ Reduced Regulatory Review Times
Submit standardized reports that meet regulator expectations.
✅ Improved Research Collaboration
Enhance data sharing across institutions and countries.
✅ Increased Patient Safety and Research Integrity
Ensure accurate and transparent reporting of clinical outcomes.
✅ Integration with Health IT Systems
Support electronic health records (EHR) and clinical data repositories.
✅ Enhanced Competitive Edge in Clinical Research
Demonstrate compliance and excellence to sponsors and partners.
© Growth Management Corporation. All rights reserved.
Growth Management Corporation is a management consulting firm that provides consulting, training, implementation, and certification services and solutions to organizations of all sizes, and all domains.
