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.

Example:

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

More

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

References

  • ISO 20387:2018 Biotechnology – Biobanking- General Requirements for Biobanking (access liable to costs)

Swiss Law

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
Abbreviations
  • CTU – Clinical Trials Unit
  • EP – Emergency Plan
Development ↦ Management ↦ Biobanking ↦ Emergency Plan
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Management ↦ Biobanking ↦ Emergency Plan

Please note: the Easy-GCS tool is currently under construction.