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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, GCP states that original trial documents must be stored for at least 15 years after the end of the trial.

We have temperature monitored archive room to store the records. The records retention schedule of patient files is governed by the relevant SOPs and regulations.

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