ICH-FDA Good Clinical Practice Managing Clinical Trials 2015 is a webinar that covers topics such as:
- Informed Consent
- The Principles of ICH GCP
- Ethics & IRB Responsibilities
- HIPPA Compliance
- Sponsor Responsibilites
- Investigator Responsibilities
- CRO Selection
- Quality Management
- Trial Management
- Trial Design/Protocol
- Data Handling/Recordkeeping
- Investigator Selection
- Monitoring
- Essential Documents
- FDA Warning Letters
- Auditing/ Regulatory Authority Inspections
ICH-FDA Good Clinical Practice Managing Clinical Trials 2015 is intended for:
- Clinical Research Associates
- Clinical Quality Assurance Professionals
- Investigators
- Project Managers
- GCP-Focused Regulatory Affairs Professionals
- Study Coordinators
