Specific rules for medicinal products
Archiving of clinical trials with medicinal products
The research documents that clinical investigators and sponsors are obliged to draw up and store before and during a clinical trial on medicinal products shall be archived according to different rules depending on whether the review application has been submitted according to the old regulations or according to the new EU regulation 536/2014.
For clinical trials on medicinal products conducted in accordance with national legislation and EU Directive 2001/20 / EC
According to the old regulations, research documents must 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.
For clinical trials on medicinal products conducted in accordance with EU Regulation EU 536/2014
According to the new EU regulation, the sponsor and the investigator must archive the contents of the trial file for at least 25 years after the end of the clinical trial, unless a longer filing period follows from other parts of Union law. However, the study participants' patient records must be archived in accordance with national law. The research documents must be archived on such a medium that it is complete and readable throughout the period in question.