What is it? Why is it important?
Biobank Management addresses the collection and handling of biological material used in studies.
- 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
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.
In order to ensure reproducibility and comparability of analytical results, sample handling processes and practices must be consistent.
- 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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
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
- ISO 20387:2018 Biotechnology – Biobanking- General Requirements for Biobanking (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