Related Guidance, Tools & Templates

• FDA Guidance for Clinical Trial Sponsors
• NIH Policy for Data and Safety Monitoring
• Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
• FDA Guidance: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring 
• FDA Webinar: Risk-based Approach to Monitoring Clinical Investigations

UCLA Presentations:

• Data Monitoring: Assuring Safety & Study Integrity in Clinical Research 
• Managing the Practice of Research