Risk Based Clinical Trial Monitoring
Duration : 75 Minutes
Marie Dorat,
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years experience, in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; Read more
This course clarifies the role of the Clinical Research Monitor and explains their responsibilities under the FDA-ICH GCP guidelines. This course will also discuss interactions with others in key roles as part of the clinical trial as well as exploring some aspects of clinical trial monitoring.
Course Objectives:
This course will provide guidance on best practices for conducting clinical investigation monitoring. We will explore strategies for dealing with common clinical trial monitoring issues. The course also summarizes the essential documentation required during the clinical trial and gives an introduction to the key requirements of clinical trial project management.
Course Outline:
By the end of this course, participants will have a understanding of:
• The principles and requirements of GCP
• Define the roles and responsibilities of sponsor/CROs, monitor, investigators and clinical site staff
• The Monitoring – What is expected?
o Risk Based Monitoring approach
o Preparation, conduct & follow-up
• Reviewing source documents & CRFs
o Essential clinical trial documentation – must haves
o Interacting with the Clinical Site
• Detect and prevent fraud
• Misconduct in clinical trials
• Communicating with the Sponsor/CRO and Investigator
o Monitoring Reports & Follow-ups
• Preparing for sponsor audits & regulatory authority inspections
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Clinical Trial Mentors
• Principal Investigators/Physicians
• New CRAs
• Clinical Site Staff
• Lab Managers and Analysts
• Regulatory Affairs Personnel
• Administration in charge of Clinical Research
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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