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
Clinical Site staff