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) (human and non-human origin) and associated data. Its organised framework ensures the quality of BM and its associated data used in research, including diagnostic and therapeutic purposes.
BB activities include the regulation and harmonisation of processes used for the handling of BM. This includes the entire life-cycle of a given biological sample, referred to as the "sample workflow", and includes sample:
What do I need to do?
As a SP-INV, make yourself familiar with the field of biobanking, such as:
- Infrastructure and technical equipment (e.g. access-controlled storage rooms, freezers, 24-hour temperature monitoring)
- Resources for managing a BB (e.g. BB staff, infrastructure, finances)
- Software to document and track BM (e.g. BIMS)
- Processes to ensure the ongoing quality of BM during the entire sample workflow
- Training of personnel responsible for BB activities
- Restricted access and adherence to data protection laws
- BB-governance and SOPs that define 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.
Ethic & Legal
- Ethical, legal and professional compliance list for human research biobanks applicable in Switzerland
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 of biobanking
HRO – see in particular article
- Art. 5 Storage of biological material