Sponsor–laboratory declaration template
Laboratory capability questionnaire for an outsourced cell-based study
A browser-local questionnaire that helps sponsors and laboratories document the exact site, materials, methods, limits, evidence, data returns, responsible roles and availability behind one proposed cell-based study.
SingularCell Research. Reviewed for primary-source scope, declaration semantics and unsupported claims. This template makes information reviewable but never qualifies, ranks, certifies or recommends a laboratory.
How to use this resource
Use this worksheet for one request version, one legal entity, one performing site and one declared time window. Record limitations and unknowns explicitly, avoid confidential details, and transfer approved answers into your controlled system of record.
Entries stay in this browser page and are not submitted to SingularCell. Download or storage is not implied.
Laboratory declaration coverage checklist
Use these prompts to confirm that the proposed work is described precisely enough for qualified people to review without turning field presence into capability approval.
Working laboratory declaration
Draft a bounded response here, then move approved information into the controlled system your organisation uses for due diligence, study records and version history.
Record the request version, legal entity, performing site, declarant, effective date and reconfirmation trigger.
Describe the exact activity, material or cell context, intended use, inclusions, exclusions, assumptions and dependencies.
List procedure versions, instruments, software, controls, ranges, variability, performance evidence and proposed substitutions.
Describe sample receipt, storage, preparation, custody, phase owners, subcontractors, deviations and correction handling.
Specify raw and processed formats, identifiers, metadata, software context, manifests, reports, delivery, retention and version history.
Record lead time, capacity window, dependencies, data locations, access, confidentiality, evidence limitations, unknowns and conflicts.
Safe questionnaire response states
Keep these states distinct so incomplete or confidential information remains visible without being converted into a capability score or pass/fail decision.
| State | Meaning | Safe review action |
|---|---|---|
| DECLARED | A value was supplied for the exact scope and version | Display the declaration and its source without calling it verified |
| DECLARED_WITH_LIMITATION | A value was supplied with a condition, range or exclusion | Keep the limitation adjacent to the value |
| CONDITIONAL | The answer depends on a named sponsor input or later confirmation | Show the dependency, owner and due date |
| NOT_DECLARED | No answer was supplied | Request clarification without inferring inability |
| UNKNOWN | The declarant explicitly does not know | Preserve the unknown and assign follow-up ownership |
| DECLINED_CONFIDENTIAL | The answer or evidence was withheld under a stated boundary | Show the review limitation and do not treat evidence as inspected |
| OUTSIDE_DECLARED_SERVICE | The laboratory says the activity is outside its offered scope | Record the exact declaration without generalising capability |
| CONFLICTING_DECLARATIONS | Supplied answers or evidence disagree | Present every version and require accountable resolution |
A complete questionnaire makes a laboratory's exact offer and unresolved gaps easier for qualified people to review. It does not prove capability, suitability, accreditation coverage, equivalence, compliance or likely success.
Bind every answer to one exact scope
Start with one request version, the laboratory's exact legal entity, the physical site proposed for each phase and the dates for which the declaration applies. Keep subcontractors and additional sites separate so one organisation's statement is not silently attributed to another performer.
A laboratory name, logo, broad service category or generic certificate is not enough to establish what is offered for this study. If accreditation is claimed, link the exact issuer record and scope while leaving coverage interpretation to qualified reviewers.
- Record the request identifier and version
- Record the legal entity and performing site
- Name the declarant, role and declaration date
- State the effective and reconfirmation window
- List every subcontractor or additional site separately
Describe the proposed work and evidence exactly
Ask for the exact biological material, cell source and state, method or procedure identifier, instrument and software context, controls, applicable ranges and known limitations. Preserve whether each answer is declared, conditional, unknown, out of scope, confidential or linked to evidence.
Matching assay or cell-line names do not prove that two implementations or biological states are equivalent. Evidence links improve traceability, but their presence does not prove that a declaration is true, sufficient or scientifically appropriate.
- Identify the material, cell source and relevant state
- Name the method, procedure and version
- Record instrument, software and configuration context
- State controls, ranges, conditions and limitations
- Link each evidence item to the declaration it supports
Make handoffs, data returns and unknowns visible
Document sample receipt and storage, phase ownership, data formats, raw and processed returns, metadata, provenance, deviations, corrections, retention, security boundaries and time-bound availability. Keep commercial assumptions separate from scientific scope.
Missing, conflicting or confidential information should remain visible rather than converted into a pass or fail. Qualified sponsor, laboratory, scientific, quality, security and legal reviewers decide what is sufficient for the actual study context.
- Assign an accountable owner to every phase and handoff
- Specify raw, processed and metadata returns
- Describe deviation and correction handling
- Record security, confidentiality and retention boundaries
- Preserve unknown, conflicting and confidential states
Primary sources
- NIST NVLAP — Accreditation vs. Certification ↗National Institute of Standards and Technology · Accreditation is bounded by an exact scope and does not certify products or test data or guarantee laboratory performance.
- NIST — NVLAP Handbook 150:2020, Update 1 ↗National Institute of Standards and Technology · Accreditation administration binds legal identity, facilities, requested scope, materials, methods, parameters, ranges, uncertainty, representatives and status dates.
- NATA — R&D scope-of-accreditation descriptors ↗National Association of Testing Authorities, Australia · R&D scope descriptors can identify material, determination, technique, capability statement, procedure and range or limitation.
- NATA — Testing in support of research and development annex ↗National Association of Testing Authorities, Australia · Within its accreditation context, the annex addresses objectives, responsibilities, samples, methods, QC, data, limitations, reporting, variability and performance monitoring.
- NIH — Authentication of Key Biological and Chemical Resources ↗National Institutes of Health · Key resources such as cell lines can differ between laboratories or over time, supporting exact identity and authentication-plan fields.
- NIST — Building Measurement Confidence for Cell Characterization ↗National Institute of Standards and Technology · Cell measurement confidence depends on intended use, process conditions, reproducibility, uncertainty, range and performance evidence.
- NIST — Research Data Framework, Version 2.0 ↗National Institute of Standards and Technology · Research-data planning can keep tools, configurations, data, metadata, security, versions, responsible parties and provenance visible.
- W3C — PROV-O: The PROV Ontology ↗World Wide Web Consortium · PROV-O represents entities, activities, agents, derivation, attribution, association, generation, use and invalidation.
Limitations
- This questionnaire records laboratory-supplied declarations and evidence links; it does not determine whether those declarations are true or scientifically adequate.
- It does not qualify, rank, recommend, certify or approve a laboratory or determine competence, trustworthiness, accreditation coverage, suitability, equivalence, compliance, acceptance thresholds or expected outcomes.
- The field set is a SingularCell product synthesis, not a universal minimum endorsed by NIST, NATA, NIH or W3C, and every source remains bounded to its stated context.
- Accreditation evidence must be reviewed against the exact issuer, legal entity, site, scope, status, dates and limitations; a logo or generic certificate is insufficient.
- Do not enter confidential, personal, proprietary, regulated or customer study information into this public browser page.