Compliance Trainings, Online
2016-06-09
Description : 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
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