# Biobank specimen tracking that knows the box, the position and the consent

> Biobank specimen tracking is the record of every biological specimen from collection through processing, aliquoting, storage, distribution and destruction, including exact location, consent status and handling history. Human subjects protection sits in 45 CFR Part 46, the Common Rule as revised in 2018, and the National Cancer Institute publishes Best Practices for Biospecimen Resources, now in its 4th edition. Neurobird binds consent to the aliquot and records every excursion and custody transfer against the specimen itself.

- URL: https://neurobird.com/biobankspecimen/
- Product: Neurobird Biobank Specimen Tracking Audit Platform
- Niche: biobank specimen tracking
- Buyer: biobanks and research biorepositories
- Status: in development, open for early access
- Updated: 2026-08-21

## What Neurobird Biobank Specimen Tracking does

- Track specimens from collection through processing, aliquoting, storage and release
- Hold freezer, rack, box and position so a pull list is a route rather than a search
- Bind consent status to the specimen so withdrawal actually blocks distribution
- Record excursions, freeze thaw cycles and custody transfers against the aliquot, not in a binder

## How it works

1. **Accession once** Collection, processing and aliquoting are recorded as they happen, with parent and child relationships kept, so provenance is never reconstructed later.
2. **Know the position** Freezer, rack, box and position are held per aliquot. A pull list becomes a walking route, and a misplaced box shows up as a discrepancy rather than a rumour.
3. **Bind consent to the specimen** Consent status and withdrawal apply at the specimen level and block distribution, so the policy is enforced by the system rather than remembered by a person.

## From the source material

> The received order sets up a specimen-tracking process that is a central LIMS function.

Source: pmc.ncbi.nlm.nih.gov, https://pmc.ncbi.nlm.nih.gov/articles/PMC7150189/

## Industry context

- **4th edition** The National Cancer Institute publishes Best Practices for Biospecimen Resources, covering governance, ethical and operational standards for repositories. (source: NCI Biorepositories and Biospecimen Research Branch, https://biospecimens.cancer.gov/bestpractices/)
- **45 CFR 46** The Common Rule for protection of human subjects, which governs consent, secondary research use and what a repository may release. (source: eCFR, 45 CFR Part 46, https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46)
- **21 CFR 58** Good Laboratory Practice for nonclinical laboratory studies, the standard specimen handling is held to when the work supports a regulated submission. (source: eCFR, 21 CFR Part 58, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58)
- **1988** Clinical Laboratory Improvement Amendments requirements, in force since 1988, apply when specimen testing produces results used for patient care, adding a second compliance regime to the same freezer. (source: CMS, Clinical Laboratory Improvement Amendments, https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments)
- **Public guidance** Federal biospecimen research programmes publish protocols and quality guidance openly, which is what a reviewer will compare your SOPs against. (source: NCI Biospecimen Research Network, https://biospecimens.cancer.gov/)

## Pricing

- Single site: $250 per repository, per month
- Multi study: $520 per repository, per month
- Network: $900 per repository, per month

## Questions

### What is biobank specimen tracking?

Biobank specimen tracking is the record of every biological specimen from collection through processing, aliquoting, storage, distribution and destruction, including its exact location, its consent status and its handling history. The unit is usually the aliquot, and a 10,000 subject cohort can easily become 200,000 of them.

### Which rules apply to a research biorepository?

Human subjects protection sits in 45 CFR Part 46, the Common Rule, which governs consent and secondary use. Repositories supporting regulated studies may also work to Good Laboratory Practice in 21 CFR Part 58, and clinical testing to the Clinical Laboratory Improvement Amendments of 1988. The NCI publishes Best Practices for Biospecimen Resources, now in its 4th edition.

### Why does consent withdrawal cause problems?

Because consent is captured in the study system and the specimen sits in a freezer under a different identifier. If nothing joins them, a withdrawal is a policy rather than a control, and a shipment can go out that should not have.

### Does this replace our LIMS?

No, and it will not pretend to. It handles specimen location, custody, consent binding and condition history. Assay data and study data stay wherever they already live, joined by identifier.

### Can it handle temperature excursions?

Yes. An excursion is recorded against the affected positions, not against the freezer in general, so you can say exactly which aliquots were exposed and for how long.

## Sources

- [NCI Best Practices for Biospecimen Resources](https://biospecimens.cancer.gov/bestpractices/)
- [45 CFR Part 46, protection of human subjects](https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46)
- [21 CFR Part 58, Good Laboratory Practice](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58)
- [CMS, Clinical Laboratory Improvement Amendments](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments)

## Contact

- office@neurobird.com
- https://neurobird.com/