Good clinical practice rules
In a nutshell: Hold what ICH E6(R3) asks of investigators and sponsors, from delegation and consent to safety reporting, records and monitoring
Use it when: You are running, monitoring or inspecting a clinical trial and want its good clinical practice duties in one place.
- CC-PDM-1.0
- Sources
- 1
- Rules
- 230
- Field
- Clinical research
- Authors
- International Council for Harmonisation, published by the U.S. Food and Drug Administration
Contains 230 Rules
Clinical trial participation should be voluntary and based on a consent process that ensures participants (or their legally acceptable representatives, where applicable) are well-informed.