What is it? Why is it important?
In studies, different storage requirements become necessary.
Main requirements include storage of:
- Biological samples
- Required study documents
- Additional material neded during study implementation
- Archived study documents/meterial upon study completion
Storage facilities must guarantee:
- Access control with restricted admission only provided to applicable study staff
- Audit trail tracking storage and retrieval (e.g. inventory control)
- Stable environmental conditions such as temperature and humidity control
- Protection against fire, and rodent infestation
Facilities should be monitored on an ongoing basis to ensure that above requirements are met.
What do I need to do?
Based on your study, define storage requirements and its management.
Evaluate and clarify:
- How access to appropriate storage facilities can be restricted and controlled and how access can be documented
- How temperature and humidity are monitored and documented
- How emergency procedures are implemented in the event of failure (e.g. freezer breakdown)
- How to guarantee inventory oversight
- How to select potential qualified storage partners (e.g. biobanking)
Ensure staff is trained regarding procedures on storage requirement including handling of emergency events.
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
- Suitability and availability of infrastructure
Swiss Exp.Com.Biosafety – see in particular
- Transport of biological material
ICH GCP E6(R2) – see in particular guidelines
- 4 Site-INV qualification
- 5 SP-INV responsibilities
ISO 14155:2020 Medical devices – see in particular sections (access liable to costs)
- 9 Responsibilities of the sponsor (SP-INV)
- 10 Responsibilities of the principal investigator (Site-INV)
ClinO – see in particular articles
- Art. 18. Storage of Health data and biological material
- Art. 45. Data Retention
HRO – see in particular article
- Art. 5. Storage of health data and biological material