What Rules Must Trials Follow?

Clinical trials must follow strict rules to protect participants and ensure scientific integrity. These include:

• ICH-GCP (International Council for Harmonisation – Good Clinical Practice): A global standard for how trials should be run
• HIPAA (Health Insurance Portability and Accountability Act): U.S. law that protects personal health information
• FDA (U.S.), EMA (Europe), CDSCO (India): National agencies that regulate trials in their regions
• IRB/Ethics Review: Required for every study involving human participants

These rules help build trust in the research process and ensure participant safety and privacy.