Concept↦Biobanking↦Biobanking in Studies↦Sample Quality
What is it? Why is it important?
The quality of any information provided by the analysis of Biological Material (BM) will highly depend on its handling conditions (e.g. sample workflow). Only standardized and traceable biobanking processes can provide confidence in analytical results.
BM used for research is mainly collected based on a:
- Specific purpose, such as from participants in a given study (e.g. the research purpose is defined in a study protocol)
- More general purpose, such as the context regarding the further-use (e.g. the research purpose is defined after the collection of BM)
Leftover BM can also be used for further-use research purposes. It encompasses potentially leftover material not used in a study or needed for diagnostic purposes. Leftover BM originates from:
- Study participants
- Hospital patients following diagnostic or therapeutic procedures
- Organ donations from living or dead humans
Irrespective of the source of acquired BM, donors of BM must agree to have their biological specimens and data used for research.
What do I need to do?
In order to have confidence in your research results, ensure you only use high quality BM for research.
Quality checks include:
- Documentation of sample workflow or BM life-cycle (e.g. from collection to analysis)
- Infrastructure management:
- Routine maintenance (e.g. freezers, laboratory equipment)
- Temperature surveillance of storage equipment
- Emergency procedures (e.g. freezer breakdown)
- Biobanking governance
- Responsibilities/Personnel Management
- Access control (e.g. BM storage, documentation)
- Quality control and ongoing risk assessments (e.g. implementation of risk control-measures)
- Regulatory requirements
Not only researchers want to ensure access to high quality BM, but also publishers of scientific journals want confidence that results were obtained from high quality samples. Only professionally managed biobanks are able to deliver the required confidence.
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
- Improvement Management SOP
- Quality policy
- Quality Manual
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) – see in particular section
- 7.8 Quality control of BM and associated data
- 8 Quality management system requirement