Archiving and Retention of Clinical Trial Documentation

As specified in GCP, the sponsor as well as the investigator / institution (i.e. investigational site) should maintain essential trial documents in accordance with applicable regulatory requirements. Essential study documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. However, these documents should be retained even longer if required by applicable regulatory requirements or else agreed with the sponsor.

In addition to GCP requirements, the Finnish Medicines Agency Regulation 2/2012 states that original trial documents must be stored for at least 15 years after the end of the trial. The records retention schedule of patient files is governed by the relevant general provisions and regulations. Trial registers are governed by the provisions of the Personal Data Act.

In general, the sponsor is advised to make a separate archiving agreement with a licensed local archiving company, or with institutional archives through University Hospital Clinical Trial Unit services, and to include a mention of the archiving contract in the clinical trial agreement and study budget. Normally the archiving is paid by Sponsor. Alternatively, a separate agreement for transfer of clinical study site documentation may be made between the sponsor and the investigational site (i.e. investigator and the clinic), and the Research Organizations when contracts are operated through it.