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Specific rules for medicines

Archiving clinical trials with medicines

The research documents that clinical investigators and sponsors are obliged to draw up and store before and during a clinical medicine study shall be archived for ten years after the study has ended and the final report has been drawn up. If the clinical study is part of a marketing application, the documents shall be archived for longer than ten years. The sponsor and clinical investigator may also agree that the documents shall be archived for longer than ten years.

More information about archiving can be found on the European Medicines Agency's website (pdf, 184 kB)external link, opens in new window