Archiving / Record Retention
Archiving instructions apply to research administered through Clinical Research Institute HUCH.
Archiving / Record Retention
The commissioning party pays for the archiving, while the research team (where appropriate, the commissioning party’s representative) shall pack up and list the material to be archived and order the required transportation.
How to Send Documents for Archiving
These archiving instructions apply to research administered through Clinical Research Institute HUCH. First, make sure with the Study Management Coordinator of Clinical Research Institute HUCH if the research archiving has been agreed on with the 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. Under the EU regulation, the statutory archiving period for clinical trials is 25 years and for device trials it is 10 years, but for implantable devices, however, it is 15 years. For studies conducted under previous directives, the corresponding periods were 15 and 5 years. Note 30 years regards to advanced therapy medicinal products (ATMP) according to European Medicine Authority´s guideline (EMA/INS/GCP/856758/2018).
As a general rule, the research sponsor 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.
The company we use to provide archiving services does not require the sealing of the material to be archived, but if the material is sealed, the archiving company is not allowed to open it.
Ordering Packaging Material
The material will be packaged in 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, Investigator File), 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 that will be filled with the following information:
- The commissioning party’s research code and contact information
- Contact information of the HUS principal investigator
- 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 the archiving service
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 to and HYKSinstituutti[at]hus.fi.
The contract prices of Clinical Research Institute HUCH include the transportation of material to Iron Mountain on weekdays Mon-Fri between 9 a.m. and 3 p.m.