What is it? Why is it important?

The collection of Biological Material (BM) might involve potential health risks to donors (e.g. infection, hematoma, bleeding and headache after a spinal tap).



In the event that the establishment of a Biobank is an integral part of a research project (HRO project) or clinical study (ClinO, ClinO-MD, Other studies), the project leader, Site-INV, or SP-INV are responsible to implement measures to ensure donor safety.



Safety events where it cannot be excluded that the event is attributable to the sampling of BM, requires the implementation of safety reporting procedures, such as the reporting of:

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 or include the description of required safety measures in the study protocol.

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


Swissmedic – see in particular

  • Human medicine: Safety measures in clinical trials


Declaration of Taipei – see particular principles

  • 19 Protection of donors

ICH GCP E6(R2) – see in particular  guidelines

  • 4.11 Safety reporting

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

  • 4 General requirements

Swiss Law

HRA – see in particular article

  • Art. 15 Safety and protective measures

ClinO – see in particular articles

  • Art. 37 Notification of safety and protective measures
  • Art. 39 Documentation of AE
  • Art. 40 Documentation and reporting of SAE
  • Art. 42  Documentation and reporting of SAE for in vitro MD
  • Art. 63 Documentation and notification of SAE

ClinO-MD – see in particular articles

  • Art. 32 Documentation of AE
  • Art. 33 Reporting of SAE
  • Art. 34 reporting of safety and protective measures

HRO – see in particular article

  • Art. 21 Serious event definition and reporting


  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trails Unit
  • HRA  - Human Research Act
  • HRO – Human Research Ordinance
  • ISO – International Organization for Standardization
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Development ↦ Biobanking ↦ Safety ↦ Donors

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): Development ↦ Biobanking ↦ Safety ↦ Donors

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