What is it? Why is it important?
- A quality check reviewing:
- Documentation of BM integrity (e.g. no or few non-conformities during sample workflow)
- Storage duration (e.g. maximum storage duration has not been exceeded)
- Request for BM retrieval from the biobank
- BM retrieval and transport to the analysis site
- Prior to analysis, potential quality controls (e.g. cell viability, adequate cell count, stable RNA)
- Documentation of BM handling prior to analysis (e.g. intermediate storage on ice, defrosting at room temperature, sterile environment)
- Analysis procedures and the occurrence of non-conformities
- Lessons learned (e.g. suggestions regarding sample-workflow steps improvement)
Analysis of BM can either be based on:
- Standardized and validated methods
- A study applicable laboratory manual
What do I need to do?
Define procedures for sample analysis. Prior to analysis review deviations in:
- Sample-workflow steps potentially affecting sample quality (e.g. sample handling between sample collection and analysis)
- Sample storage conditions and duration (e.g. no sup-optimal temperature fluctuations, maximal storage duration were not exceeded)
- Sample retrieval from biobank storage (e.g. date, time, transport means and temperature)
- Intermediate storage prior to analysis (e.g. room temperature, on ice, -20°C)
- The analysis and quality deviations (e.g. analysis date and time, non-compliance with analytical methods)
- Qualified staff responsible for BM retrieval from storage and analysis
In the event of unexpected or incorrect results, check potential interferences with sample-workflow steps (e.g. from collection until analysis). Ask yourself what conditions might have influenced the quality of BM. By the ongoing improvement of sample-workflow steps, the provision of high quality BM and credible research results can be guaranteed.
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.