Executive Development Programme in Clinical Trial Data Security Protocols

• Fundamentals of Clinical Trial Data Security: Understanding the importance of data security in clinical trials, common threats, and basic security measures.
• Data Privacy Regulations: Overview of regulations such as HIPAA, GDPR, and 21 CFR Part 11, and their impact on clinical trial data security.
• Access Control and Authentication: Implementing proper access controls, user authentication, and authorization methods for clinical trial data.
• Data Encryption and Transmission Security: Techniques for encrypting data at rest and in transit, and securing data transmissions.
• Physical Security and Infrastructure: Protecting physical infrastructure, implementing secure disposal practices, and managing visitor access.
• Incident Response Planning: Developing incident response plans, conducting risk assessments, and establishing breach notification procedures.
• Security Audits and Compliance: Performing security audits, maintaining compliance with industry standards, and monitoring for vulnerabilities.
• Disaster Recovery and Business Continuity: Designing disaster recovery plans, ensuring business continuity, and implementing backup and recovery strategies.
• Training and Awareness: Educating staff on security best practices, raising awareness on phishing and social engineering attacks, and fostering a security-conscious culture.