What Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 58: Archiving of the clinical trial master file requires
The sponsor and investigator must archive the clinical trial master file for at least 25 years after the trial's end, ensuring it is accessible, legible, secure, and that all alterations are traceable.
Pillar: Biotech & Genomics · Authority: European Parliament and Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0536
SHA-256 integrity: 6e88c0d7f9a4a6e5eb377cd3bd8ffa66c988679ecac709b9650f694c2d553afc
Primary Citations — 7 traced to source
- Article 58, first paragraph: ...the sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial.
- Article 58, first paragraph: However, the medical files of subjects shall be archived in accordance with national law.
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