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.