What is it? Why is it important?
A biobank (BB) is an organized entity with a governance in place, responsible for the management of Biological Material (BM). It provides an organised framework required to ensure the quality of BM used in research as well as for diagnostic and therapeutic purposes.
BB activities include the regulation and harmonisation of processes used for the handling of BM, such as biological sample:
Biological samples are BMs of human and non-human origin
What do I need to do?
As a SP-INV, make yourself familiar with requirements needed for the management and set-up a BB, such as:
- Required infrastructure and technical equipment (e.g. access controlled storage rooms, freezers, 24 hour temperature monitoring)
- Required resources needed for BB management
- Software needed for the documentation and tracking of BM (e.g. BIMS)
- Processes to ensure the ongoing quality of stored BM (e.g. correct handling, processing, storage conditions)
- Training of BB responsible study personnel
- Restricted access and adherence to data protection laws
- A BB governance document that defines BB management and responsibilities
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
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
Swissethics – see in particular
- Topics / Biobanks and data registries
Declaration of Taipei – see in particular
- Health database and biobank governance
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost)- General Requirements for Biobanking – see in particular section
- 3.6 definition biobanking
HRO – see in particular article
- Art. 5 Storage of biological material