Codex of clinical research
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Welcome to the Codex of clinical research!
Clinical research generates evidence that advances understanding of diseases and informs effective treatment. In every clinical trial, data integrity and participant protection are of paramount importance.
This site is a modest knowledge base dedicated to the planning and conduct of clinical trials.
The content focuses on established best practices, regulatory requirements, and industry standards drawn from reputable sources. Each topic is grounded in authoritative definitions from regulatory authorities, professional organizations, and recognized standards. Where applicable, references to primary sources and official guidance are provided.
Our mission
This site covers the essential components of clinical research through organized information on core topics including:
- Regulatory affairs: FDA, EMA, ICH guidelines, IND/CTA submissions and approval processes, marketing authorizations, and post-market requirements
- Ethics and participant protection: IRB/IEC oversight, informed consent, vulnerable populations, and safety monitoring
- Site operations: investigator responsibilities, patient recruitment, investigational product management, and documentation
- Safety management: adverse event reporting, risk assessment, and pharmacovigilance
- Quality control and assurance: clinical monitoring, GCP compliance, audits, and corrective actions
The material is intended for investigators, research coordinators, monitors, and quality personnel who require clear, trusted definitions in the context of clinical research.