Your Easy Guide to Clinical Studies

Main activities and responsibilities of biobanking staff include:

• Biobank set-up (e.g. management of facilities and materials, sample coding and packaging, storage equipment and maintenance)
• Handling of biological material (BM) (e.g. sample-workflow, sample destruction)
• Biobank governance (e.g. risk-based QMS, document management, safety, compliance with EC and regulatory requirements (HRA, HRO))

 

Based on performed activities and responsibilities, biobanking staff can include a:

• Biobank operational manager responsible for biobank governance, including staff management
• Quality manager who writes SOPs/WIs needed for the daily during of the biobank, including the monitoring of quality indicators
• Data manager who manages the electronic documentation of Biological Material (e.g. BIMS)
• Logistics manager who manages facilities and materials, consumables, equipment, including its ongoing surveillance and maintenance
• Laboratory technicians who process and analyze Biological Material (BM)
• Study coordinator who manages / coordinates the collection, transport and processing of BM

Based on the set-up of your biobank:

• Define required staff needed for the smooth running and management of your biobank. Ensure staff resources are adequate to guarantee the ongoing correct administration and quality management of your biobank
• Consider the need to outsource biobanking services. Remember that the responsibility to safeguard the quality of purchased services remains with the biobank
• Based on delegated biobanking responsibilities, ensure staff have the appropriate qualifications, required trainings, and ongoing required education (e.g. specific processing techniques, the management of the biobanking database)
• Set-up individual training plans for each staff member, and ensure they remain current. Retrain as necessary
• Document biobank qualifications and trainings (e.g.CV, job description, training-logs)

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

External Links

Swissethics – see in particular

• Topics / Biobanks and data registries

References

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) – see in particular section

• 6 Resource requirements

Swiss Law

HRO – see in particular articles

• Art. 4 Professional qualifications
• Art. 5 Storage of health-related personal data and biological material