What is it? Why is it important?

Once collected, a biological Specimen must remain traceable during the entire storage duration, including analysis.


The aim is to be able to allocate a biological specimen to a specific:

  • Donor, if the person must remain identifiable (e.g. samples are not anonymized)
  • Collection date, and if applicable time
  • Collection sequence (e.g. individual donors provide samples at different time points)
  • Sample type (e.g. serum, whole blood, urine)
  • Affiliated project or study (e.g. institution, hospital, division)
  • Study site in multi-center studies


Sample identification is for the most part accomplished by sticking a label, with the required information, on a sample collection container.

For multi-center studies, labels can be generated and distributed by a central laboratory. This guarantees that labelling procedure across study centers remains harmonized.


Donor identity must be protected by replacing donor identifiers (e.g. name, date of birth, address) with an individualised code. For donor re-identification, a donor-identification-log, linking codes with donor identifiers can be generated. The log must be kept access protected and separate from the biobank.


Biological Material (BM) can also be anonymized. Anonymisation procedures are not trivial, as it is difficult to guarantee that a BM cannot be re-identified. Planned anonymisation procedures must therefore be submitted to EC for approval. The donor has also the option abstain from anonymization, which must be taken into consideration.

What do I need to do?

When creating a sample labelling system comply with the following guidelines:

  • Preferably use:
    • Numerical codes (e.g. use individualized project IDs, sample type IDs), or
    • Bar- or QR codes (e.g. BIMS can generate a labelling structure)
  • Create unique donor IDs (e.g. keep a donor-ID-Log for donor re-identification)
  • Create unique specimen IDs needed to differentiate between multiple specimens provided by the same donor (e.g. specimens collected at different time points)
  • Abstain from entering codes or information by hand. Entries by hand are highly prone to errors both during sample labelling, and subsequent entries into a biobanking database (e.g. BIMS). If entries must be made by hand, ensure to use a freezer compatible pen
  • Select labels that are freezer compatible (e.g. cryolabels), processing proof (e.g. use of solvents), and suitable for long term storage. This will ensure that labels remain glued to sample containers and its information remains legible


Based on your project:

  • Ensure sample labelling is guaranteed throughout sample-workflow processes (e.g. from sample collection until analysis)
  • Plan ahead and generate an adequate amount of labels, such as:
    • Number of collected samples
    • Number of generated aliquots upon sample processing
    • Template(s) / questionnaire(s) used to enter sample related information


If possible and in order to reduce labelling errors, pre-label sample collection tubes including respective templates. Train staff on labelling procedures and introduce quality checks that guarantee procedures are correctly implemented

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

  • BM Management SOP
  • Sample tracking Form
  • Participant Identification Log

External Links

Swissethics – see in particular

  • Topics / Biobanks and data registries


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

  • 7.5 Traceability of biological material and associated data



  • BM – Biological Material
  • BIMS – Biobank Information Management System
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ID – Identity
  • ISO – International Standards Organisation
  • SBP – Swiss Biobanking Platform
Set-Up ↦ Biobanking ↦ Sample Management ↦ Sample Traceability

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 ↦ Sample Management ↦ Sample Traceability

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