- Topics
- ICH E6: (GCP)
- ICH E6 (R2): Good Clinical Practice
- Good Clinical Practice: Guidance for Industry
- ICH E6 (R2) Investigator
- Adequate Resources
- Records and Reports
- Investigators as Sponsors
- Quality Management
- Trial Management, Data Handling, and Record keeping
- Monitoring Plan
Nancy Pire-Smerkanich, DRSc, MS
Associate Director, Regulatory Knowledge and Support