What is it? Why is it important?

Biobank Management addresses the collection and handling of biological material used in studies.

Includes:

  • Facilities: restricted access
  • Sample collection:
    • Type: (e.g. liquid, tissue, organ, healthy/diseased)
    • Quality: (e.g. collection, shipment, processing, storage)
  • Storage method: (e.g. fresh-frozen, formalin-fixed, paraffin-embedded)
  • Documentation: (e.g. sample-ID, storage location, link to patient data)
  • Risk assessment: (e.g. emergency plan by equipment failure)
  • Data confidentiality (coding / anonymisation): guaranteed

More

Adequately trained staff must be available for the management of biobank tasks.

Upon collection, biological samples should be coded as quickly as possible. This ensures that participant identity remains concealed, and data protection issues are respected at all times. This is especially the case if biological samples are shipped to an external laboratory for analysis.

In order for the Site-INV to re-identify participants, the code is matched with patient name and date of birth on a “participant identification log” located in the ISF.

What do I need to do?

Define and train biobanking collection and storage processes:

  • Based on planned analysis define pre-analytical prerequisites
  • Ensure temperature control, access rights, sample traceability
  • Perform regular quality checks to test whether procedures (e.g. collection, processing, storage) are performed according to study and quality guidelines
  • Write up biobanking governance procedures based on responsibilities, further use, training

For more information refer to Biobanking in this Study Guide.

More

In order to ensure reproducibility and comparability of analytical results, sample handling processes and practices must be consistent.

Define standardised:

  • Collection procedures based on sample type (e.g. collection tubes, approved stabilisers)
  • Sample processing and storage conditions
  • Analytical procedures

Ensure traceability of steps:

  • Define maximum acceptable time-lapse between different processing steps (e.g. delays between sample collection, processing, storage, and analysis)

Make sure sample handling and processing steps are well documented.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

swissbiobanking.ch. – see in particular

  • National coordination for human and non-human biobanks

Efbs.admin.ch – seen in particular

  • Transport of biological material

Swissethics - see in particular

  • Biobank Regulation

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
  • ID – Identity
  • ISF – Investigator Site File
  • Site-INV – Site-Investigator
Development ↦ Management ↦ Biobanking ↦ Management
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 ↦ Management

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