2015 - 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