Clinical Trial Monitoring - Documentation and Closure 2016

Key Topics

• Case Report Forms vs Source Documents: Can these be kept electronically?
• Essential documents: What are they? Where can I get examples? Who is responsible for maintaining and generating these?
• Sample materials such as a study closure checklist
• Considerations when deciding to close a study
• Common audit findings and how to avoid these
• Close out visit and Internal audits practices
• ICH GCP E6

Who should Attend

• Healthcare interested in exploring the field of Clinical Research
• Human Subjects Research
• Administration in charge of Clinical Research, Clinical Research Sites
• Clinical Research Coordinator positions
• Principal Investigator positions, Sub-Investigators
• Contract Research Organizations , Clinical Research Associates, Regulatory Coordinators
• Monitors and auditors