Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting

Course Objectives

• List the various regulatory and other necessary documents that are essential before, during and at the end of clinical trials, and how and when they must be collected, reviewed and filed by sponsors and investigators 
• Describe the procedures for initiating individual investigational sites and for conducting investigator meetings for multi-center trials
• Understand the potential issues with subject recruitment and retention in studies and the steps that may be taken to improve both
• Describe the regulations, issues and other considerations in conducting studies in the global arena, with a detailed look at the move toward harmonization 
• Understand the purpose of monitoring and list the steps involved in conducting routine monitoring visits 
• Describe the data-review process during monitoring in terms of CRF review and source document verification (SDV)
• Discuss the importance of drug accountability and describe the necessary procedures for drug accountability by the investigational site, monitor and sponsor
• Understand what adverse and serious adverse events are
• Discuss the importance of adequate safety reporting, and the required timelines, documentation, and procedures for recording and reporting safety data 
• Describe the processes involved in individual site close-out and at study close-out 
• Provide references to governing regulatory requirements, guidelines and best practices

What You Learn

• Trial master files
• Investigator files
• Document collection, review and filing
• Site initiation steps and checklist
• Subject recruitment rate
• Overcoming subject drop-outs
• Global drug development environment
• Harmonization of regulations and guidelines
• Routine monitoring visit checklist
• Data review process (case report forms and source document verification)
• Study drug accountability procedures and documentation
• Adverse and serious adverse events
• Site close-out
• Post-study review

How You Learn

• Lectures
• Reading assignments
• Online discussions
• Written assignments
• Midterm and final exams