UNIT 6: Regulatory Framework and Good Clinical Practice (GCP)
This unit explains the regulatory framework governing clinical research and the principles of Good Clinical Practice that ensure ethical conduct, subject protection, and data credibility. It details the roles and responsibilities of regulatory authorities, sponsors, investigators, and trial staff as required by international guidelines.
Clinical trials are regulated by national and international authorities to ensure that research involving human subjects is ethical, scientifically sound, and legally compliant. While regulatory structures vary across countries, global harmonization efforts aim to standardize expectations so that clinical data can be accepted across regions.
| Region | Regulatory Authority | Primary Responsibility |
|---|---|---|
| United States | FDA | Authorization and oversight of clinical trials |
| European Union | EMA / National Authorities | Scientific evaluation and supervision |
| India | CDSCO | Approval and regulation of trials |
| Global | WHO | Guidance and international standards |
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