What is it? Why is it important?
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
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
- BM Management SOP
- Sample tracking Form
- Participant Identification Log
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