Topics:
- E6(R2): Good Clinical Practice: Integrated Addendum to ICH (International Council for Harmonisation) E6(R1): Guidance for Industry
- INVESTIGATOR (4)
- Adequate Resources (4.2)
- Records and Reports (4.9)
- SPONSORS (5)
- Quality Management (5.0)
- Trial Management, Data Handling, and Record Keeping (5.5)
- Monitoring Plan (5.18)