Concept↦Biobanking↦Regulatory Requirements↦Biobank Goverance
What is it? Why is it important?
The aim of a biobank governance is to ensure that the management of the biobank is running based on:
- Applicable laws (e.g. HRA), ethics requirements (e.g. EC, Decl. of Taipei) and biobanking guidelines (e.g. ISO)
- Harmonised processes
- Allocation of responsibilities
- Required resources, infrastructure and equipment
- Re-traceable and access protected documentation
- Law compliant database including qualified IT support
- Correct handling of Biological Material (BM)
- A risk-based QMS including the planning of risk control-measures
- Defined contact points
- An organigram including reporting timelines
- Required education and ongoing training of biobanking staff
- Subject rights and Informed Consent from all subjects donating BM for research
What do I need to do?
The Swiss Biobanking Platform (SBP) can assist you with many of the requirements addressed in ISO and the Declaration of Taipei. They can provide you with support including documents needed for the set-up and competent running of a Biobank.
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 particular principle
- Health database and biobank governance
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) – see in particular
- 8 Quality management system requirement
HRA - See in particular
- Art. 43 Storage
HRO – see in particular article
- Art. 5 Storage if biological material