Your Easy Guide to Clinical Studies

Biobanking is an integral part of study conduct. During study visits Biological Material (BM) is collected and analysed, with results providing 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.

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)

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.