As a Clinical Data Management adhering to the CIA Triad (Confidentiality, Integrity, and Availability) is critical in managing sensitive clinical trial data. While I don’t have personal experiences, I can share an illustrative scenario based on common challenges in clinical data management:
Incident: Breach of Confidentiality
What happened?
An email containing participant IDs and sensitive clinical data was inadvertently sent to an unauthorized recipient due to human error. The email was not encrypted, increasing the risk of data exposure.
How did it affect the system or users?
• Compromised participant privacy, potentially violating regulatory requirements like HIPAA.
• Erosion of trust with trial participants and stakeholders.
How to prevent it?
• Implement secure communication protocols: Use email encryption tools and ensure sensitive data is shared only through secure platforms.
• Training and awareness: Conduct regular training sessions for staff on data handling and security protocols.
• Role-based access control: Ensure only authorized personnel can access sensitive information.