What is it? Why is it important?

Measures should be taken to ensure donor safety, as the collection of Biological Material (BM) might involve potential health risks (e.g. infection, hematoma, bleeding). Health risk occurrences are documented, with special procedures for Serious Events (SE).


A SE is a health risk attributed to the sampling of BM. In the event of a SE, the project leader of a HRO project must interrupt the project and inform the EC within 7 days. The EC decides on the safety of the project and its continuation within 30 days.


A SE is an adverse event where it cannot be excluded that it is attributable to the sampling of BM, and which:

  • Requires inpatient treatment not envisaged in the protocol, or extends a current hospital stay
  • Results in permanent or significant incapacity or disability; or
  • Is life-threatening or results in death


In order to guarantee participant (donor) safety, further events can be defined in the protocol. The EC can also request that additional events (not included above) are listed and handled as serious.

SEs that occur in connection with an investigation involving a radiation source on which the FOPH has delivered an opinion, require that the SE is additionally reported to the FOPH within 7 days.

What do I need to do?

Define potential risks to donors as a result of the collection of BM. Document risks and define risk control-measures to reduce risks.


Risk control-measures can include to:

  • Exclude certain risk groups (e.g. donors with low haemoglobin, haemophilia, pregnancy)
  • Limit the collection volume (e.g. blood volume, number of biopsies)
  • Equip facilities for the safe collection of BM (e.g. sterile environment, professional staff)
  • Limit blood draws to 2 attempts (e.g. avoid to prick the donor more than 2 times)
  • Train staff on collection safely measures (e.g. disinfect injection site, ware protection gloves)
  • Monitor donor status after the collection of BM (e.g. normal blood pressure)
  • Monitor donor and train staff on the handling of post collection adverse events (e.g. drowsiness, pain, bruises)


Write an SOP on how to ensure donor safety. Define how to manage risk occurrence in research a project, and how to proceed in the event of a SE.

Donor risk assessment can also be documented in a project relevant Risk Assessment Form.

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.

SBP Documents

SOPs, Forms and Templates – see in particular

  • Safety and complaint SOP

External Links

Swissethics – see in particular

  • Topics / Biobanks and data registries


Declaration of Taipei – see particular principles

  • 9 Data protection and patient rights
  • 10 Confidentiality
  • 19 Protection of donors

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section

  • 4 General requirements

Swiss Law

HRO – see in particular article

  • Art. 21 Serious events


  • BM – Biological Material
  • CTU – Clinical Trails Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HRO – Human Research Ordinance
  • ISO – International Organization for Standardization
  • PBMC – Peripheral Blood Mononuclear Cells
  • SBP – Swiss Biobanking Platform
  • SE – Serious Event
  • SOP – Standard Operating Procedures
Development ↦ Biobanking ↦ Safety ↦ Donors

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
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 Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Biobanking ↦ Safety ↦ Donors

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