Archiving / Record retention
The Sponsor pays for the archiving, while the research team (or where appropriate, the Sponsor’s representative) packs up and lists the material to be archived and orders the transportation.
How to send documents for archiving
These archiving instructions apply to research administered through Clinical Research Institute HUCH. The archiving services are bought from Iron Mountain Incorporated, a company located in Vantaa. Please make sure with the Research Management Coordinator of Clinical Research Institute HUCH if the research archiving has been agreed with the sponsor (or commissioning party).
The listing and compilation of research-related documents into individual archive series ensures that the documents are retained, discovered (retrieved) and destroyed after statutory storage. In 2019, the statutory archiving time is 15 years in clinical research and five years in equipment studies. Following the European regulations, these are going to change into 25 and 10 years, respectively; the date for this amendment is still open.
As a general rule, the commissioning party (or Sponsor) of the research pays the archiving costs to Clinical Research Institute HUCH. The main responsibility for archiving lies with the researcher and the research team, but the commissioning party’s representative can be asked for help if necessary.
Iron Mountain does not require sealing of the material to be archived, but if the material is sealed, Iron Mountain cannot open it.
How to order packaging material:
The material will be packaged in the Iron Mountain archive boxes (Standard Carton Equivalent, SCE), which are ordered from the HUS Logistics central warehouse, in connection with a normal stock order, with code S7030 ARKISTOLAATIKKO+KANSI Iron Mountain. The price of the box is included in the research expenses. An RFID label is also required, which you should mention separately when placing the order.
In other hospital areas, packaging materials are ordered from their local warehouses with code S7030.
Packaging and listing of the material:
When organizing a dossier for archiving, consider the following:
- Individual documents shall be in document boxes or folders
- Document boxes/folders shall provide the content data (e.g. (CRF, ICF, researcher’s folder), date of creation, and year of destruction
- The material to be archived is packaged in archive boxes for transportation and final archiving
- The box holds up to 5 (7 cm) document folders.
- The weight of the archive box must not exceed 12 kg
- The archive boxes must be labeled with a barcode (e.g. RXXXXXXXXX)
Here you can download an Excel list (in Finnish) that will be filled with the following information:
- The commissioning party’s research code and contact information
- Contact information of the HUS researcher in charge
- Project number (2XXXX or 3XXX) of Clinical Research Institute HUCH
- Each box is recorded on a separate row with its own bar code number
- The contents of the folder are described in the material section
- Date of destruction
- Date of creation
- Retention period
- The paper material list is delivered with the boxes to Iron Mountain
Submission of material for archiving:
The material is registered in the archiving system according to the material list, not the entries made on the archive box.
The material list must be sent to Iron Mountain and Clinical Research Institute HUCH no later than one day before the material is transported, by email: arkisto@IronMountain.com and HYKSinstituutti@hus.fi.
The contract prices of Clinical Research Institute HUCH include the transportation of material to Iron Mountain on weekdays Mon-Fri between 9 am and 3 pm. The transportation is ordered by email or by phone from Iron Mountain (email@example.com / tel. +358 (0)9 825 6020).
For additional information, please contact:
Head of Research Services Raimo Skottman, tel. +358 (0)40 660 2290, ext-raimo.skottman (at) hus.fi
or the Research Service Coordinators of Clinical Research Institute HUCH.