Life Science — Clinical Data Audit Trail Management

Overview

The purpose of the Clinical Data Audit Trail Management DAG is to create a comprehensive audit trail that tracks all modifications made to clinical data, which is critical for ensuring data integrity and regulatory compliance in the life sciences industry. The architecture consists of a secure data ingestion pipeline that captures events related to the creation, updating, and deletion of clinical records. Data sources include clinical trial databases, electronic health records (EHR), and laborat

The purpose of the Clinical Data Audit Trail Management DAG is to create a comprehensive audit trail that tracks all modifications made to clinical data, which is critical for ensuring data integrity and regulatory compliance in the life sciences industry. The architecture consists of a secure data ingestion pipeline that captures events related to the creation, updating, and deletion of clinical records. Data sources include clinical trial databases, electronic health records (EHR), and laboratory information management systems (LIMS). The ingestion pipeline processes these data sources in real-time, employing robust security measures to ensure that only authorized personnel can access sensitive information. Processing steps include event logging, data validation, and security checks, which are essential for maintaining data quality and compliance with industry regulations. Each modification event is recorded with timestamps and user identifiers, ensuring traceability. Outputs from this DAG include a secure audit log, compliance reports, and alerts for unauthorized access attempts. Monitoring KPIs include the number of modifications tracked, access attempts, and compliance report generation frequency. This DAG not only enhances data security and compliance but also provides valuable insights into data management practices, ultimately contributing to improved decision-making in clinical research and patient care. By implementing this audit trail, organizations can mitigate risks associated with data breaches and ensure adherence to regulatory standards, thereby enhancing their reputation and operational efficiency.

Part of the Customer Personalization solution for the Life Science industry.

Use cases

• Enhances data integrity and traceability in clinical trials.
• Ensures compliance with regulatory standards like HIPAA.
• Reduces risks associated with data breaches.
• Improves operational efficiency through streamlined audits.
• Facilitates better decision-making based on accurate data.