Reference cardRegulations and guidance
Where is E8(R1), the one on how studies should be designed and run?
FDA publishes ICH E8(R1), General Considerations for Clinical Studies, as a guidance document on its website. It is listed in the FDA guidance documents section.
Next steps
- Read the FDA guidance page for E8(R1), General Considerations for Clinical Studies.
From the question: Where is E8(R1), the one on how studies should be designed and run?