What is it? Why is it important?

A specimen is a specific quantity of Biological Material /BM) (e.g. blood, tissue, urine, saliva, DNA/RNA, hair, stool) taken from a single subject at a specific time (human, animal, plant or other).

A sample is a single unit, taken from a given specimen.


Specimens can be:

  • Alive or deceased
  • Of human, animal, plant or other origin
  • Infectious (e.g. bacteria, virus)
  • Radioactive
  • Genetic, non-genetic or genetically modified


Specimens are used:

  • For diagnostic, therapeutic, or surgical purposes
  • For the development of new treatments or technologies


Human specimens should always be treated as biohazardous and potentially infectious.


The following specimens are not considered of human biological origin:

  • Commercial reagents containing human components or cells
  • Non-human specimens (e.g. laboratory animal or plant specimens)
  • Microbiological, viral or fungal agents


Specimens may also be referred to as biospecimens or primary samples.

Samples may also be referred to as biological samples, biosamples, or derivatives.

What do I need to do?

When using specimens for research, familiarise yourself with the following requirements:

  • Donors must agree to their BM being used for research purposes:
    • In human research the participant or legal representative signs an ICF
    • In animal research the owner signs an ICF
  • Documentation must be stored in a project database that is compliant with:
  • Handling and storage procedures must guarantee ongoing quality and traceability of specimens


The recording of specimens and samples needs to include information on:

  • Origin (e.g. person/animal/plant identifiers, health history, diagnosis)
  • Handling (e.g. sample workflow)
  • Analytical results (e.g. sample analysis, reference range)


To obtain meaningful research results, a large number of samples is often necessary. Having access to sufficient patients with the required characteristics (e.g. lifestyle, age, sex, pathology, genetics) can be challenging.


BBMRI-ERIC is a European biobanking research infrastructure dedicated to support researchers in high quality biomedical research. They manage a catalogue of available biospecimens including its associated data across Europe. As an infrastructure, they can provide you with valuable support in accessing specific biospecimens.

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

  • Biological material management SOP


Declaration of Taipei – see in particular

  • Health database and biobank governance

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

  • 3.45 Definition sample

Swiss Law

HRO – see in particular article

  • Art. 5 Storage of biological material
  • BB – Biobank
  • BBMRI-ERIC – Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • HRO - Human Research Ordinance
  • ICF – Informed Consent Form
  • ISO – International Standards Organisation
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Basic ↦ Biobanking ↦ Definition ↦ Specimen / Sample

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): Basic ↦ Biobanking ↦ Definition ↦ Specimen / Sample

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