EudraLex - Volume 10 - Clinical trials guidelines_Chapter III_Quality of the investigational medicinal Product.

EudraLex Volume 10 – Clinical trials guidelines – is the main European Commission web portal for guidance documents that support the legal framework for clinical trials on medicinal products. It consolidates templates, detailed guidance and question‑and‑answer documents that explain how to implement the Clinical Trials Regulation (EU No 536/2014) and, where still applicable, Directive 2001/20/EC. The site is updated when new or revised guidance is adopted, making it a current and authoritative source for regulatory requirements affecting both academic and commercial trials.

The website is organised into two main sections: one set of documents applicable to clinical trials under the Clinical Trials Regulation (EU No 536/2014) and a second set applicable to trials under Directive 2001/20/EC. Within each, guidance is grouped into six chapters, each listing specific guidance titles with direct links to downloadable PDF and Word files, allowing users to navigate quickly to the materials most relevant to their role. The chapters are as follows.

Chapter I (application and application documents) provides application‑related documents, such as Clinical Trials Information System (CTIS) materials, site suitability forms, investigator curriculum vitae templates, informed consent‑related templates and documentation on biological samples. 
Chapter II (safety reporting) includes guidance on development safety update reports and on the collection and reporting of adverse events and adverse reactions in clinical trials. 
Chapter III (quality of the investigational medicinal product) focuses on the quality requirements for investigational medicinal products, including expectations for chemical and pharmaceutical quality documentation and for good manufacturing practice, handling and supply. 
Chapter IV (good clinical practice inspections) covers the preparation, conduct, reporting and follow‑up of good clinical practice inspections. 
Chapter V (additional information and thematic guidance) brings together further guidance on topics such as first‑in‑human and early clinical trials, International Council for Harmonisation (ICH) good clinical practice, advanced therapy medicinal products, clinical trial master file content and specific ethical topics, including the conduct of paediatric clinical trials. 
Chapter VI (legislation) provides links to the key legal acts underpinning clinical trials in the European regulatory system, including the Clinical Trials Regulation and related delegated and implementing acts.

For investigator‑initiated trials, Volume 10 supports regulatory compliance across the study lifecycle, from trial design and application through trial conduct, safety reporting and investigational medicinal product management, to inspection readiness and archiving.