Archiving
Archiving of paper documentation at the end of the trial should be avoided if possible. All study documentation can be stored electronically, see SOP Avslutning og arkivering av kliniske legemiddelstudier (Completion and Filing of Clinical Drug Trials) and SOP Study Files. We recommend creating an archive log for recording of dates when documents are sent for archiving and scheduled date for shredding / deletion.
OUS has an agreement with Iron Mountain on the storage of paper documents. Pasientarkiv (the patient archive department) handles registration of boxes and transport to the storage facilities.
When sending trial documents to Iron Mountain, the following procedure must be followed:
- Archive boxes can be ordered by sending an e-mail to Pasientarkiv: aenge@ous-hf/ monafu@ous-hf.no.
- Documents should be removed from binders and plastic covers and placed in the boxes.
- A label with information about the study name, responsible PI, date of storage and planned date for shredding should be completed in duplicate. One copy should be kept by the site, the other put in the boxes with the documents. Boxes should be marked with contact person Anne Marie Enge, tel. +47 23075739
- Pick-up and transport can be ordered from the transport department (link to the OUS intranet) at the individual study site. The time it takes from ordering to collection of boxes depends on capacity and therefore may vary.
- Pasientarkiv records boxes, affixes bar code labels from Iron Mountain and provides transportation to the storage facilities.
- If the study site needs to retrieve archived boxes, contact Pasientarkiv who will arrange for Iron Mountain to bring the boxes to the site.