All blueprints

Keep the permission with the specimen.

Biobank and biorepository management software that keeps consent, provenance and scientific quality with each specimen, so a research request is assessed against the permission as well as the freezer match.

Illustration of a seal beside a microscope, screening plate and cryovials.
Fictional research request in the actual Seal interface: three fully loaded candidate records link recorded volume, findings and versioned consent evidence.
Three linked candidate assessments. Each specimen has enough volume, but recorded scope, recipient review and a withdrawal hold lead to different decisions. No dispatch is authorised. Fictional example in Seal; published versions are not release approvals. View full size

Figure 1. Fictional research request BB-REQ-026 in Seal: three candidate specimens each hold enough volume, but recorded consent scope (C-017), recipient review and a withdrawal hold (WR-019) lead to different decisions. No dispatch is authorised.

Summary

The problem
A freezer search finds specimens with the right matrix and volume, but whether they may be used depends on consent documents, restrictions and withdrawals kept elsewhere. A local hold does not show what collaborators or datasets still hold.
Seal’s approach
Each specimen carries its source permission, provenance, storage history and derivatives. A research request becomes a reviewable package of candidate evidence, exclusions and approvals, and a withdrawal is traced through stored, distributed and derived material.
What changes
Finding candidates and authorising use stay distinct. Reviewers can see why the same specimen is in scope for one use and not another, with the source document behind each assessment.
Where to start
One collection and a representative research request, including a changed purpose and a withdrawal. Book a demo.

1A freezer match is only the beginning.

A researcher can find the right matrix, timepoint and volume and still be unable to use the specimen. The proposed research must be assessed against its recorded permission, current restrictions, scientific suitability and distribution requirements. Keep that assessment connected to the material and its history.

The fictional request in Figure 1 asks for 0.30 mL per specimen for external genomic analysis. All three candidates have 0.50 mL. BB-017 is outside its recorded consent scope, BB-018 still needs review, and BB-019 has a withdrawal hold. The query has found candidates; it has not authorised a shipment.

The specimen is unchanged. The proposed use is not.

C-017 / recorded scope

BB-017 / plasma

0.50 mL in storage

ONCO-21 research only.

External genomic analysis is not included in the recorded permission.

ICF-017 · 12 May 2021
Fictional source summary

Change the proposed use

Outside the recorded scope

BB-REQ-026 proposes a different use. C-017 does not record permission for external genomic analysis. Keep BB-017 outside this allocation unless an authorised review establishes a valid basis.

  • Requested purpose is not included
  • Retain the source and the exclusion reason
  • No allocation or dispatch authorised
Figure 2. Change the intended research use and see why the same specimen has a different scope assessment

1.1Why teams choose Seal for biobanking

A research request asks whether each candidate specimen may be used for a stated purpose. In a biobank run on a freezer inventory system, with consent forms, restrictions and withdrawal notices in document folders and distribution records in spreadsheets, the answer comes from cross-checking them by hand. Seal records each specimen with its permission, its derivatives and each distribution, so eligibility for a proposed use is assessed from the source document and a withdrawal reaches aliquots and shipped material. neil can assemble the candidate evidence for a request; the access committee decides.

2Keep the source behind every permission.

Record the participant or source code, collection protocol, consent document and version, date, recorded scope and any relevant institutional determination. Keep the original source available to authorised reviewers. A summary field makes the assessment searchable; it does not replace the document or decide how it applies.

Capture the distinctions the collection needs: study-specific or future research, analysis type, recipient restrictions, commercial involvement, data sharing, recontact and return-of-results provisions. Represent missing, ambiguous and conflicting evidence explicitly. Do not translate an unanswered question into permission.

Fictional native Seal consent record C-017 showing coded participant D-017, source summary, effective date and the external-genomics restriction.

Fictional records in the actual Seal interface. Published identifies a saved version, not permission for research use. View full size

Figure 3. The current Seal consent-scope record retains its fictional source, effective date and proposed-use restriction

Changes need their own history. Link a new consent or determination to the record it updates, retain effective dates and identify which specimens, derivatives, requests and distributions need reassessment. Recontact work needs an authorised scope, assigned owner and recorded outcome; not every unanswered request can be resolved by obtaining a new form.

3Trace withdrawal beyond the stored tube.

A withdrawal request starts an assessment of scope and action. Preserve what was received and when, identify the affected specimens and associated data, and record the restrictions needed while the request is assessed.

Stored aliquots, distributed material and derived data need different follow-up. A local inventory hold does not establish what a collaborator still holds, whether a dataset remains in use, or which prior work can be affected.

A withdrawal reaches beyond the freezer.

WR-019 / fictional request received 7 September 2026

BB-019 / stored aliquot

New dispatch held

0.50 mL remains in storage. Keep BB-019 out of new allocation while the withdrawal is assessed.

Decision
Authorised disposition or continued retention
Evidence
The action taken, who performed it and when

A hold records a restriction. It does not prove that the specimen was destroyed.

Figure 4. Follow the stored specimen, prior distribution and derived data through separate withdrawal actions

WR-019 keeps those branches in one assessment. New dispatch is held in the fictional workflow. Recipient follow-up and data review remain open. Record acknowledgements, authorised disposition, execution evidence and any limits on what can be retrieved or changed.

Fictional native Seal withdrawal assessment WR-019 with fully loaded stored-material, recipient and data follow-up records and their open states.

Fictional records in the actual Seal interface. Published identifies a saved version, not permission for research use. View full size

Figure 5. The actual Seal withdrawal assessment links separate follow-up records and their unresolved states

4Preserve scientific value through storage and transformation.

Collection provenance includes the source, method, time, processing delay, matrix, additives and initial condition. Processing links the procedure, equipment, operators, reagents and actual quantities to every resulting aliquot or derivative. A daughter tube keeps its lineage; it does not automatically gain permission for another use.

Model the real storage hierarchy: site, freezer or tank, rack, box and position. Retain moves, temporary locations, retrievals, thaws and returns. Reconstruct occupancy during a temperature event using the event interval and custody evidence; the current freezer map alone cannot establish the exposed population.

Quality is purpose-specific. Keep viability, integrity, concentration, freeze-thaw history and the source measurements beside the requested method’s requirements. An acceptable concentration cannot substitute for an unresolved condition history. Preserve the quantity consumed by testing even if its result is later invalidated.

Explore sample management and equipment controls.

5Make the research request a reviewable work package.

A request defines the research question, study, recipient, specimen criteria, amount and associated data needed. Search within the requester’s permitted records. Keep the candidate evidence, exclusions, reservations, scientific review and applicable agreements with the request rather than spreading the decision across correspondence.

After the required approval, connect the allocation to the pick, scanned container, packing conditions, logger, custody, shipping details and recipient receipt. A substituted tube needs its own eligibility check. Receipt discrepancies, returned residuals and subsequent use belong in the same history.

Track the outputs as well as the dispatch: analyses, derived datasets, publications and acknowledgements can link back to the distributed specimens. Report the underlying records and counting rules so one publication using many specimens is not accidentally counted many times.

6Give neil the evidence and the work to prepare.

Ask neil to compare the proposed research with permitted source documents and specimen records, reconstruct a withdrawal’s downstream scope or configure the request workflow from your protocol. It can prepare linked assessments and configuration for review, not just a written recommendation.

“Prepare this external research request. Show which specimens need a different decision and why.”

neil / proposed workIllustrative draft

Inputs: BB-REQ-026 + permitted specimen and consent records

A candidate assessment with its evidence

BB-017
Outside recorded scope; retain C-017 as the source
BB-018
Recorded scope is relevant; recipient and suitability review pending
BB-019
Withdrawal hold; retain the link to WR-019

Create linked candidate assessments and review tasks. Compare alternatives without silently extending permission, clearing a hold or approving dispatch.

neil uses the operator’s permissions. People interpret requirements, verify changes and make access, suitability and approval decisions.

Figure 6. Explore concrete proposed assessment, follow-up and configuration work that neil can prepare

For a new cohort request, ask for candidate specimens and explicit inclusion and exclusion reasons. For a withdrawal, ask for stored descendants, prior distributions, associated datasets and unresolved recipient actions. Missing custody or source evidence should become a linked question, not an invented conclusion.

For a new collection, ask neil to author templates, required fields, references and review states, then prepare verification cases: missing consent evidence, a changed purpose, a withdrawal arriving before dispatch, an insufficient aliquot and an unauthorised attempt to complete the request. It can assemble the proposed change with requirement links and the affected operating procedures.

neil operates within the user’s permissions. Authorised people interpret the source and institutional requirements, assess suitability, verify configuration and approve or publish changes. A draft does not grant access to participant identity or authorise specimen use.

7Separate research access from participant identity.

Design access around the role and purpose. A researcher may need a coded specimen record and a limited set of characteristics; a custodian or authorised identity-linkage role may need different information. Keep that distinction in the configured permissions and verify it through search, references, exports and API access.

A code is not proof of anonymity. Decide where identity mappings are held, who may access them, what can be exported and how linkage or re-identification is authorised and recorded. Do not place direct identifiers in the research-facing specimen title, free-text notes or a broadly accessible attachment.

Use the collection’s institutional governance and applicable requirements to define those controls. The NCI Governance Best Practices provide a reference for governance planning; they do not replace local review or demonstrate software compliance.

8Keep retention, disposition and continuity explicit.

Retention follows the collection’s governing protocol, agreements and institutional decisions. Preserve the rule, triggering event, review date and any active holds. An elapsed date should identify work to review, not silently dispose of a specimen.

Authorised disposition records the exact material or data in scope, method, executor, time and evidence, with a witness where required. Preserve the history according to the applicable retention and access requirements. A completed local action does not close outstanding recipient follow-up.

Plan for the repository itself: equipment failure, emergency transfers, staffing changes, system recovery and collection transfer or closure. Link procedures, training, equipment evidence and continuity tests to the work. Accreditation and compliance depend on the institution’s applicable scope, implemented controls and evidence, not on a software label.

Explore laboratory operations and quality management.

AOperating model

Included in this blueprint

  • Sample collection
  • Consent management
  • Storage mapping
  • Chain of custody
  • Sample requests
  • Aliquoting and derivatives
  • Quality and viability testing
  • Temperature monitoring
  • Identity and research access
  • Quality and accreditation evidence
  • Sample lifecycle management
  • Publication and impact tracking

Connected across Seal

BCapabilities

Table B.1. What the Biobank and Biorepository Management blueprint covers. Linked capabilities are blueprints of their own.
CapabilityWhat it covers
Sample collectionProtocol, source code, collection and processing times, matrix, condition and source consent evidence remain linked to the specimen.
Consent managementRetain source documents, recorded scope, effective dates and review decisions. Missing or changed permission remains visible for each proposed use.
Storage mappingRepresent freezer, tank, rack, box and position. Retain historical occupancy and verify moves against the actual container.
Chain of custodyFollow stored material, prior shipments and recipient follow-up. A later action does not overwrite the earlier handoff.
Sample requestsCompare candidates with the requested purpose, quantity, recipient and scientific criteria. Keep the evidence and exclusions with the review.
Aliquoting and derivativesPreserve parent–child lineage, quantities, process loss and consumption. Review permission and suitability for the derivative’s intended use.
Quality and viability testingLink viability, integrity, concentration and condition evidence to the intended analysis. Retain source measurements and unresolved exceptions.
Temperature monitoringConnect storage equipment and custody history to the event interval and source monitoring evidence. Review candidate exposure before making a suitability decision.
Identity and research accessConfigure role-appropriate specimen and identity access. Verify search, references, exports, APIs and attachments against the intended permissions.
Quality and accreditation evidenceConnect procedures, training, equipment, deviations and continuity tests. Assemble evidence for the institution’s applicable assessment scope.
Sample lifecycle managementFollow withdrawal, retention holds, authorised disposition and recipient acknowledgements without treating a flag as a completed action.
Publication and impact trackingLink distributions to analyses, datasets and publications. Keep attribution and counting rules explicit when reporting repository use.

CConnected records

Entity hierarchy
What it records
Kind
Specimen
Biological sample. Collection provenance, consent, storage location, quality status.
entity
Whole Blood
EDTA, heparin, citrate. Primary collection. Derivative source.
template
Plasma
Anticoagulated blood derivative. cfDNA, proteomics, biomarkers.
template
BB-017 / plasma aliquot
Fictional coded specimen: 0.50 mL, linked C-017 scope and a proposed external research request.
record
PBMC
Peripheral blood mononuclear cells. Viable, cryopreserved. Immunology.
template
FFPE Tissue
Formalin-fixed paraffin embedded. Room temperature. Histology, IHC.
template
cfDNA/ctDNA
Cell-free DNA extract. Liquid biopsy. Concentration, fragment size.
template
Donor
Sample source. Consent status, demographics, clinical data linkage.
entity
Storage Unit
Freezer, tank, shelf. Capacity, monitoring, maintenance. Location mapping.
entity
LN2-TANK-001
Illustrative liquid-nitrogen storage unit. Capacity, monitoring, maintenance and contingency evidence.
record
Sample Request
Request from a researcher, with criteria, approval, fulfilment and tracking.
entity
BB-REQ-026 / external genomic analysis
Fictional request for 0.30 mL per specimen. Three candidates; no dispatch authorised.
record
Consent
Informed consent record. Permitted uses, expiration, withdrawal status.
entity
C-017 / recorded scope
Fictional ONCO-21 scope summary. External genomic analysis is not included.
record
Quality Metric
Sample quality indicator. DNA integrity, cell viability, concentration.
entity
Publication
Research output using samples. Citation, journal, linked specimens.
entity
Specimen Custody Event
Container, actor, time, source, destination, condition and verification evidence.
entity
Specimen Transformation
Aliquot, pool or preparation with contributors, actual quantities, residual and loss.
entity
Research Distribution
Authorised request, selected containers, recipient, agreement, shipment and receipt.
entity
Research Use Assessment
Request-specific source permission, restrictions, suitability, recipient review and decision.
entity
Figure C.1. Record types, templates and the relationships between them in this blueprint.

DQuestions and answers

How is biobanking different from laboratory sample management?

Biobanking adds long-term custodianship, future research requests, participant permission, recipient obligations and collection continuity to physical sample management. Testing remains connected to the exact specimen, its lineage and source evidence.

Can we track specimens across multiple locations?

Model the required sites, storage units and positions, then retain source, destination, time, operator and verification for each move. Use historical custody—not only today’s location—to assess a past event.

How should consent withdrawal be handled?

Record the request and its scope, establish appropriate interim restrictions and review stored specimens, descendants, prior distributions and associated data. Keep authorised actions and unresolved follow-up explicit. The institution determines applicable obligations and limits.

Does a coded record make the data anonymous?

No. A code alone does not establish anonymity. Define the identity mapping, permitted linkage, role access and export rules, then verify them for the implemented workflow.

Can researchers search the repository?

Configure search and request access for the intended roles and fields. A candidate result is not permission to inspect participant identity, reserve material or distribute it; those actions need their own applicable controls.

How does storage monitoring connect to specimen review?

Connect the relevant event interval and monitoring evidence with recorded occupancy, transfers and condition history. Identify candidate exposure and missing evidence for review. Confirm the specific integration and coverage during implementation.

Does Seal itself establish biobank accreditation or compliance?

No. Applicable standards, institutional procedures, configuration, verification and operating evidence determine the assessment. Seal can hold linked procedures, training, equipment and sample histories; a software label is not accreditation.

What happens when a new research use is proposed?

Create a request-specific assessment against the source permission, restrictions, recipient, agreements and scientific requirements. Preserve ambiguous or missing evidence. Do not carry an earlier approval into a materially different use without the required review.

What happens when specimens reach the end of retention?

Identify the rule and triggering event, check current holds and request authorised disposition review. Record the actual material or data acted on and the execution evidence; elapsed time alone is not proof of disposal.

What can neil prepare for a biobank?

neil can compare permitted source records, propose candidate assessments, trace withdrawal follow-up and author templates, fields and workflow checks. It can prepare verification cases and a reviewable change. People retain interpretation, access, suitability and approval decisions.

See your process in Seal.

Bring a procedure or a recurring problem. See how your team can use neil to build the workflow, investigate the results and improve the next version.

Book a demo