Clinical Trial Monitoring – What is Required?

This course clarifies the role of the Clinical Research Monitor and explains their responsibilities under the 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.

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.

Areas Covered in the Session :
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

Who Will Benefit:
Clinical Research Monitoring Professionals
Clinical Quality Assurance Professionals
New Clinical Research Associates
Study Coordinators
Clinical Site staff

Marie Dorat

Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.

Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.

She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance