Completion↦Management↦Archiving↦Storage
What is it? Why is it important?
Upon study end, study data and documents (e.g. essential documents) are archived. The aim is to retain the ability to reconstruct the study at some later date.
Archiving is the only available mean to verify that the:
- Information in the Clinical Study Report and its publications are correct
- The study team did comply with ethics requirements, the Swiss law, and applicable guidelines (e.g. ICH GCP, ISO 14155, ISO 20916)
Regardless whether documents are available as hard copies or in an electronic form, they must:
- Remain legible during the entire archiving period
- Be made available to the Ethics Committee (EC) and Swissmedic upon request
- Be traceable in the event they become removed and returned from/to the archive
- Be validated when subjected to a transfer medium (e.g. certified copies)
Archiving premises must be:
- Access restricted to prevent theft, destruction, or forgery (e.g. access with personalised badge or key)
- Protected against fire, humidity, and rodent infestation
More
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?
As a SP-INV:
- Familiarize yourself with legal archiving requirements (e.g. scope and duration)
- Provide the Site-INV(s) with an archiving SOP, including instructions on:
- Documents / data to be archived (e.g. ISF, participant-identification-log)
- Acceptable archiving premises
- Procedures for the retrieval and return of archived documents and data
- Expected duration of archiving
- Notify the Site-INV(s) when study records are no longer needed. Include destruction procedures (e.g. documentation, data confidentiality)
- Request a certificate of destruction
As a Site-INV:
- Implement the archiving SOP of the SP-INV
- As agreed, return selected data and documents to be archived with the SP-INV
- If applicable, remind the SP-INV when the archiving duration is over
- Follow required destruction procedures (e.g. documentation on how, when, and where documents were destroyed)
More
Based on the Swiss law, the archiving period of studies with an investigational:
- Medicinal Product (IMP) is at least 10 years
- Medical Device (IMD) is at least 15 years
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
References
ICH GCP E6(R2) – see in particular guideline
- 5.5.6 Data retention
ISO 14155:2020 Medical devices (access liable to costs) – see in particular section and annex
- 8.6 Document retention
ISO 20916:2049 In vitro diagnostic medical devices
Swiss Law
ClinO – see in particular articles
- Art. 18 Storage of Health-Related Personal Data and Biological Material
- Art. 45 Data retention requirements
ClinO-MD – see in particular article
- Art. 40 Document retention requirements