What is it? Why is it important?
An Emergency Plan (EP) defines processes and activities to be implemented in the event that constant storage conditions are no longer met.
There is a freezer breakdown that endangers the optimal storage condition of study samples (e.g. tissue and liquid samples).
- Procedures should be defined prior to a freezer breakdown in order to enable study staff to act accordingly in such an emergency situation.
- Setting-up and implementing an EP might require the collaboration between different departments and should be taken into consideration when defining emergency processes (e.g. technical department, service personnel, storage facility access rights)
What do I need to do?
Based on a freezer breakdown example, set-up and implement an:
- Electronic monitoring system controlling ongoing optimal storage conditions
- Alarm which is triggered in the event that storage conditions fall outside a pre-defined range(s) (e.g.- 80°C freezer warms up above -70°C)
- Emergency plan which has to be followed by all involved parties. In the event of process adaptations, ensure all parties remain trained and updated
Document the emergency event including applicable consequences or improvement measures.
For more information refer to Biobanking in this Study Guide
Staff responsible to implement emergency procedures should have easy access to required instructions and be appropriately trained.
Applicable test runs might be helpful to catch potential problems, while simultaneously train responsible staff.
Important aspects to consider:
- Who are main emergency contact persons?
- Are all involved parties aware of their individual tasks and responsibilities?
- How can a smooth running of operational interfaces be guaranteed?
- Are infrastructures and/or materials present to handle emergency scenarios (e.g. standby freezer for relocation of samples)?
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
- ISO 20387:2018 General equirements for iobanking (access liable to costs)
ClinO – see in particular article
- Art. 18 Storage of health-related personal data and biological material
HRO – see in particular article
- Art. 5 – Storage of health-related personal data and biological material