Development↦Biobanking↦Handling of Biological Material↦Sample Workflow
What is it? Why is it important?
Sample-workflow (sample “life-span”) describes a sequence of standardized steps that define how to handle and document Biological Material (BM) from collection to analysis.
Workflow steps include BM:
- Distribution (e.g. includes shipment)
The aim of workflow steps is to:
- Ensure BM are correctly handled. This guarantees that:
- Researchers are provided with BM of high quality (e.g. sample quality)
- Analytical results are highly credible
- Ensure relevant data is collected and documented in a standardised manner (e.g. data quality)
- Allow for the re-tracing of all workflow steps for quality control purposes (e.g. unexpected/false analytical results can be explained and excluded based on evidence of workflow non-conformities such as BM storage under sub-optimal temperature)
Based on the planned analysis, sample workflow steps must be planned prior to the collection of biological material.
Steps might include to define:
- BM of interest (e.g. serum, PBMC, cancer cells)
- Expected BM stability (e.g. RNA is highly unstable, requiring applicable adaptions to workflow steps)
- Required BM processing (e.g. infrastructure, equipment, expertise, cost)
- Ease of collection (e.g. donor consent and disease status, invasive / non-invasive collection procedures, regulatory requirements)
- BM optimal storage conditions and duration
- Processes for standardised documentation
What do I need to do?
Define sample workflow steps based on your planned analysis.
Ask yourself the following questions:
- What BM do I plan to collect (e.g. tissue, liquid)?
- What is the sample identification and tracking system (e.g. sample coding, BIMS)
- What additional data is needed (e.g. BM characteristics, patient demographics, disease type, donor medication intake)?
- What are the collection procedures (e.g. by surgeon or donor, required collection and storage containers)?
- How are samples transported (e.g. on ice, at room temperature, container type, safety measures, timing)?
- What are the sample processing procedures (e.g. slicing, centrifuging, aliquoting)?
- What are the required sample storage conditions (e.g. optimal storage temperature and duration)?
- How samples are protected and retrieved (e.g. storage with access control)?
- What facilities and materials are needed?
- What staff expertise is required?
- What are the expected overall costs (e.g. sample processing requirements, storage duration)?
- Document workflow steps in a SOP and/or WI. Include:
- Required facilities (e.g. premises and storage equipment, such as freezers, centrifuge, flow cytometry) and materials (e.g. consumables such as EDTA blood collection tubes, processing solutions)
- Required staff expertise including responsibilities (e.g. who is responsible to implement which workflow steps?).
- Plan quality control steps in order to ensure that workflow steps are correctly implemented (e.g. take a risk based approach)
- Create forms (digital or on paper), where staff can enter sample workflow information in a standardised manner (e.g. date & time of sample collection, sample processing steps, storage conditions)
- In the event of BM destruction ensure destruction procedures are validated and documented
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
- Biological Material SOP
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost)- General Requirements for Biobanking – see in particular section
- 7. Process requirements
HRO – see in particular articles
- Art. 4 Professional qualifications
- Art. 5 Storage of HRpD and BM in research projects