Deletion and Shredding of Archived Study Documents
For clinical drug trials, the requirement for document retention is at least 15 years after completion of the trial at all sites. Documents must be kept longer if required by other regulations or agreements.
There are specific archiving requirements for studies that include somatic cell therapy, gene therapy, or tissue regenerative therapy. For such trials, certain documents, including code lists, must be kept for 30 years.
Pasientarkiv will be notified by Iron Mountain when the registered shredding date approaches. They will contact the responsible PI /department head who clarifies with the sponsor whether shredding can take place as planned.
For deletion of information stored electronically, the responsible researcher / department head sends an email to personvern@ous-hf.no, stating which folder to delete.