ICH-FDA Good Clinical Practice – Managing Clinical Trials

Description : This course provides an overview of the critical elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to Sponsor Responsibilities and Quality Management of the clinical trial. This webinar has been specifically designed to help attendees manage a GCP compliant clinical trial. It will provide a background and understanding of the role played by the Sponsor, IRB, Investigators, and the Regulatory Authorities. Attendees will be taken through the key stages of the clinical trial processes. Areas Covered in the Session : The Principles of ICH GCP Informed Consent HIPPA Compliance Ethics & IRB Responsibilities Investigator Responsibilities Sponsor Responsibilites Quality Management CRO Selection Trial Design/Protocol Trial Management Investigator Selection Data Handling/Recordkeeping Essential Documents Monitoring Auditing/ Regulatory Authority Inspections FDA Warning Letters Who Will Benefit: Clinical Quality Assurance Professionals Clinical Research Associates Project Managers Investigators Study Coordinators GCP-Focused Regulatory Affairs Professionals