What is it? Why is it important?
A risk-based approach is a decision-making process that takes into consideration ways to identify, evaluate, prioritise, and control risks associated with some undertaking, such as a biobank.
Potential safety-risks related to the management of a biobank can include:
- The governance of the Biobank (e.g. biobanking processes, responsibilities, staff resources and training, applicable laws and guidelines)
- The management of biobanking facilities and materials (e.g. work/storage space, biobanking equipment such as freezers, pipettes, labs, consumables)
- Staff and donor safety
- The agreement and documentation of donor consent
- Handling of Biological Material (BM) (e.g. sample workflow)
What do I need to do?
Familiarise yourself with how to identify and assess potential biobanking risks. Based on risk identification:
- The likelihood of risk occurrence (probability)
- Expected impact of risk (severity) (e.g. decrease quality of BM, donor right, faulty analytical results)
- Define risk control-measures
- Communicate and train staff on risk management
- Perform risk-reviews in order to check the ongoing efficacy and applicability of risk control-measures, including the potential occurrence of new risks (e.g. new equipment, new staff, new procedures)
- Document your risk management strategy in a Risk Assessment Form
Regarding safety breaches:
- Ensure they are immediately notified, communicated, and documented (e.g. RAF)
- Perform a root cause-analysis and define control-measures to prevent its re-occurrence
- Train staff
During the ongoing management of your biobank include the documentation and handling of non-conformities (NC) in your risk-based approach.
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.
SOPs, Forms and Templates – see in particular
- Risk management SOP
Swissethics – see in particular
- Topics / Biobanks and data registries
ICH GCP E6(R2) – see in particular guideline
- 5.0 for quality management
ISO 31000 Risk Management (access liable to costs) – see in particular section
- Risk management: Principles and guidelines
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section
- 8.5 Actions to address risks and opportunities
HRA – see in particular article and chapter
- Art. 12 Risks and burdens
- Chapter 3 Requirements for research involving vulnerable persons