Basic↦Biobanking↦Definition↦Specimen / Sample
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)
- Genetic, non-genetic or genetically modified
Specimens are used:
- For diagnostic, therapeutic, or surgical purposes
- The development of new treatments or technologies
- To provide for study data (e.g. inclusion/exclusion criteria, primary endpoint)
Human specimens should always be treated as biohazard 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 biospecimen or primary sample.
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 given 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 adheres to the:
- Handling and storage procedures must guarantee ongoing quality and traceability of specimens
The recording of specimens and samples are based on their:
- Origin (e.g. person/animal/plant identifiers, health history, diagnosis)
- Handling (e.g. sample workflow)
- 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 required biospecimens.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
SOPs, Forms and Templates – see in particular
- Biological material management SOP
Declaration of Taipei – see 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
HRO – see in particular article
- Art. 5 Storage of biological material