What is it? Why is it important?

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.

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

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

  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • SBP – Swiss Biobanking Platform
Set-Up ↦ Biobanking ↦ Biobanking in Studies ↦ Procedures

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Biobanking ↦ Biobanking in Studies ↦ Procedures

Please note: the Easy-GCS tool is currently under construction.