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Validity : 13th Apr'24 to 23rd Apr'24
Clinical Monitoring – GCP Trial Expectations
- The basic principles and requirements of GCP
- Define the roles and responsibilities of sponsor/CROs, monitor, investigators and clinical site staff
- The Monitoring Visit – What is expected?
- Preparation, conduct & follow-up
- Reviewing source documents & CRFs
- Essential clinical trial documentation – must haves
- Interacting with the Clinical Site
- Detect and prevent fraud
- Misconduct in clinical trials
- Communicating with the Sponsor/CRO and Investigator
- Monitoring Reports & Follow-ups
- Preparing for sponsor audits & regulatory authority inspections
Overview of the webinar
This course will provide guidance on best practices for conducting monitoring visits. 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.
Who should attend?
- Clinical Trial Monitors
- New CRAs
- Clinical Site Staff
- All those who are new or considering clinical trial monitoring and want a clear understanding of what is really expected of them
Why should you attend?
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.
Faculty - Ms.Marie Dorat
Marie Dorat, CQA, CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 15 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 process the necessary documents for international product distribution. She is also Managing Partner at iComplyRegs, LLC which provides the most current FDA/EU/ROW regulatory requirements updates as well as experienced RA/QA Consultants