Set-Up↦Biobanking↦Biobanking in Studies↦Procedures
What is it? Why is it important?
Biobanking is an integral part of study conduct. During study visits Biological Material (BM) is collected in order to provide information on:
- Disease progression regarding the disease under investigation (e.g. metastasis)
- Study treatment effect(s) (e.g. improvement in blood parameters or tumour markers)
- Study safety with the occurrence of Adverse Events (e.g. unfavourable and unexpected changes in blood parameters)
- Primary- or secondary endpoints needed for the evaluation of the study / research project
In studies, the collection and analysis of BM (e.g sample-workflow) often requires the collaboration between different executive teams and departments. This poses additional challenges to the study team, who must ensure that collaborations and their interfaces operate as planned.
Both the quality of the BM and the integrity of the data will highly depend on a successful collaboration between participating parties.
What do I need to do?
Ensure downstream processes for the collection and analysis of BM (e.g. samle-worlflow) are correctly set-up, such as:
- Donor informed consent process, including the handling of the Donor-Identification-Log (e.g. needed for donor re-identification)
- Surgeons, study nurses, laboratory staff are trained and provided with written instructions on how to collect BM, including its documentation (e.g. study database / BIMS)
- Material needed for the collection of BM is ready (e.g. collection tubes, anonymized donor labels, dry ice, collection documentation sheets / CRF)
- Post collection processes are trained and ready for use, such as:
- Temporary storage upon BM collection (e.g. temperature-, light-, and access protected)
- Information flow between executive teams (e.g. collection site and laboratory)
- Processing of BM (e.g. according to a planned downstream analysis)
- storage (e.g. avaialble and reserved freezer space)
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.