The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion.

They shall retain the documents for a longer period, where so required by other applicable requirements or by an agreement between the sponsor and the investigator.

Essential documents shall be archived in a way that ensures that they are readily available, upon request, to the competent authorities.

The medical files of trial subjects shall be retained in accordance with national legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice.