Glossary

The biobank and system terms used throughout these docs, defined once.

Accession — to register a specimen into the system, assigning it a per-study accession ID and opening its chain of custody. Also the ID itself.

Analysis service — a named test in the catalog, with a code and a unit (for example, PSA in ng/mL). Ordering one against a specimen creates a request.

Append-only — a table that accepts inserts but rejects updates and deletes. The audit trail, custody events, results, and signatures are all append-only, enforced by database triggers.

Aliquot — a child specimen split from a parent, taking a portion of the parent’s tracked volume and carrying a parent-suffixed accession ID (like …-00002.1) and a lineage link back to it.

Bulk accession — registering many identical specimens in one action, with an option to fill sequential freezer positions as they are created.

Calculated result — a result whose value is derived from other results on the same sample by a safe server-side expression, rather than typed in.

Certificate of Analysis (CoA) — an on-demand PDF snapshot of a sample, its released results, and their QC status, content-hashed and recorded when issued.

Chain of custody — the immutable, ordered record of what happened to a specimen physically: collection, receipt, storage, transfer, aliquoting, consent-withdrawal holds, and disposal.

Collection kit — an outbound set of empty containers assembled and shipped to a site so it can collect specimens; tracked through assemble → ship → deliver.

Consumption ledger — the append-only record of every draw from a reagent lot. A lot’s on-hand quantity is its received amount minus the ledger’s draws.

Control material — a sample with a known target and standard deviation run alongside patient samples to check that an assay is in control.

Derivation — producing a new material type from a single parent specimen (DNA from whole blood, for example), recorded as lineage.

Custody event — one immutable row in the chain of custody, carrying its study reference directly so it can be scoped without a join.

DataMatrix — the 2D barcode encoded on each specimen label, alongside the human-readable accession ID.

E-signature meaning — the statement of what a signature attests to, recorded with the signature (21 CFR Part 11 §11.50).

Four-eyes — the rule that the person who enters a result cannot verify it; a second, different user must. Enforced by the system, not by procedure.

Grant — a scoped assignment of a role to a user for a specific study (and optionally a single site). Users have no standing authority without one.

Hash chain — the audit trail’s tamper-evidence mechanism: each event stores a hash of its contents plus the previous event’s hash, so altering any past event breaks every event after it.

Hold — a block placed on a sample or a whole subject (for example on consent withdrawal) that propagates to lineage descendants and prevents storing, aliquoting, or shipping. Reversible, unlike disposal.

Levey-Jennings chart — a plot of a control’s measurements over time against ±1 / ±2 / ±3 SD bands, used to spot drift and rule violations at a glance.

Manifest import — accessioning a heterogeneous batch of specimens from a CSV, validated server-side and applied all-or-nothing.

OIDC — OpenID Connect, the single-sign-on protocol used for authentication. An OIDC-only account still needs a local password to sign results.

Pooling — combining many parent specimens into one pooled sample, recorded as many-to-one lineage.

QC verdict — the quality-control status stamped on a result at entry (pass, out_of_spec, or not_evaluated) or on a control measurement (accept, warning, reject).

Reagent lot — a received batch of a catalog reagent, with a lot number, expiry, and on-hand quantity, drawn down through the consumption ledger.

Shipment — a batch of specimens moved between locations through a pack → ship → receive custody handoff, with the sending and receiving steps separated.

Requirement ID — an identifier like P11-09 or CoC-02 tying a regulatory requirement to the code that enforces it and the test that proves it, tracked in the traceability matrix.

Specification — a per-service acceptance criterion (a numeric range or a qualitative expectation), versioned by supersession, evaluated at result entry to produce the QC verdict.

Step-up authentication — re-verifying identity at a sensitive moment (here, re-entering a password to sign) even within a live session.

Subject reference — the EDC subject key and study-event OID a specimen was collected against. A pointer only; no patient health information enters the LIMS.

Vertical slice — one workflow built all the way through every architectural layer, front to back, rather than one layer built broadly. lims-core started as a single vertical slice and has since grown wider on that same core.

Westgard rules — quality-control rules evaluated on control measurements (for example 1-2s, 1-3s, 2-2s) that classify a run as accept, warning, or reject.

Worksheet — a batch of analysis orders grouped into an instrument run (draft → in_progress → completed) that consumes reagent lots.