What is it? Why is it important?
An important aim for any study or research project is the ability to:
- Provide confidence in its research results
- Contribute to the advancement in health care
To provide confidence in data retrieved from Biological Material (BM) requires that the “life cycle” or sample workflow remains traceable (e.g. from collection to analysis). This requires the introduction of standardized biobanking processes and the documentation of BM:
- Collection (e.g. method(s), timing)
- Transport and reception (e.g. means, temperature, timing)
- Processing (e.g. centrifugation, aliquoting, sequencing)
- Storage (e.g. means and temperature, storage duration)
- Distribution / shipment (e.g. means, timing, temperature)
- Analysis (e.g. methods)
Based on the type of BM, processing and storage requirements can differ significantly.
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.
BBMRI-ERIC is a European biobanking research infrastructure dedicated to support researchers in high quality biomedical research. Across Europe, they manage a catalogue of available biospecimens and its associated data. As an infrastructure they can provide you with valuable support in accessing required biospecimens.
What do I need to do?
As a SP-INV and project leader of an HRO project, make yourself familiar with the optimal handling of BM applicable to your research.
Assess aspects that ensure the quality of your BM and its implication. Quality control aspects include:
- To define quality indicators: are performance indicators regarding critical biobanking steps
- To plan data monitoring: activities that check the correctness of data entered into the biobanking database
- To include method validation: implemented tests that ensure biobanking methods and procedures are quality based and fit for purpose
During study conduct ongoing quality controls ensure:
- Defined biobanking processes and methods remain valid and are correctly implemented
- Responsibilities are clearly defined and remain trained
- The handling of BM during sample workflow is documented and traceable
- The biobanking database is correct and complete
- Study participant and donor consent is available
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.
SOP, Forms and Templates – see in particular
- Quality control strategy SOP
- Data Quality SOP
- Biological Material Management SOP
- Quality control strategy implementation SOP
- 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
Declaration of Taipei – see in particular principle
- 1 Ethical principles in medical research
ClinO – see in particular section
- Section 6 Storage of HrPD and BM in clinical studies
HRO – see in particular articles
- Art. 5 Storage of HrPD and BM in research projects
- Art. 24 General provision for further use