Clinical Trial Monitoring - Documentation and Closure
Duration : 90 Minutes
Sarah Fowler-Dixon, Clinical Research
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new pr Read more
Using Good Clinical Practice
Course Objectives:
• Describe the relevant regulations and guidance
• Provide practical information on case report forms and source documents
• Discuss
• Review considerations prior to closing a study
• Provide information for study close-out visits, audits, and procedures
• Explore ramifications of closing a study too soon
• Review common errors
Why Should You Attend:
Conducting a clinical trial can be overwhelming. Collecting good data is essential but not possible with the proper tools. This webinar will discuss good documentation practices along with pitfalls to avoid. Included will be practical applications along with advice on how to avoid common errors such as closing a study too early. The practical advice provided in this webinar will help those attending conduct a cleaner trial, leading to fewer headaches. Additionally, the webinar will provide the attendees with information on where to go when more information or advice is needed so to help dissipate the feeling of having to go it alone.
Course Outline:
• Essential documents: What are they? Where can I get examples? Who is responsible for maintaining and generating these?
• Case Report Forms vs Source Documents: Can these be kept electronically?
• Considerations when deciding to close a study
• Sample materials such as a study closure checklist
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• Common audit findings and how to avoid these
• ICH GCP E6
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Human Subjects Research
• Healthcare interested in exploring the field of Clinical Research
• Clinical Research Coordinator positions
• Administration in charge of Clinical Research, Clinical Research Sites
• Contract Research
• Principal Investigator positions, Sub-Investigators
• Monitors and auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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