What is it? Why is it important?
Upon study termination all essential and other relevant documents are stored or archived in order to reconstruct each single study step at some later date.
Archiving is the only available mean to verify:
- That the information in the CSR and its publications are correct
- The compliance of SP-INV, Site-INV, and monitor with GCP and applicable law
In Switzerland archiving of:
- IMP study is a minimum 10 years
- MD study is a minimum 15 years
Documents must be archived in a safe secure place. Archiving must guarantee that:
- Documents remain legible during the entire archiving period. This includes electronically archived data. If data or documents are transferred to another medium, its transfer system must be validated
- Only authorised personnel have access to archived study documents and material
- All documents must be made available to EC/RA upon request
- Removal and retrieval of archived documents are tracked and documented
- Premises are protected against fire, humidity, and rodent infestation including access control in order to prevent theft, vandalism, forgery, destruction and loss
What do I need to do?
Familiarise yourself with legal archiving requirements.
- Provide Site-INV with an archiving SOP that defines:
- What documents to archive
- Acceptable archiving premises (e.g. access protected, humidity fire and rodent protected)
- Processes for the retrieval and return of archived documents
- The required archiving duration including destruction procedures
- Notify the site when the archiving period has ended, and the documents can be destroyed
- Ask for certificate of destruction
As a Site-INV implement SOP archiving procedures provided by the SP-INV (e.g. SOP or WI)
For more information refer to Documents in this Study Guide.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Swissethics - see in particular
ICH GCP E6(R2) – see in particular guideline
- 5.5.6 data retention
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 8.6 Documentation retention
ClinO – see in particular article
- Art.45 data retention