Section 02
Core concepts
Workspaces, trials, protocol versions, criteria, datasets, cohort runs and screening records.
- Workspace
- A partition of an organisation with its own members, trials and data-class ceiling.
- Trial
- A study being recruited. Holds protocol versions, cohort runs, screening records and site assignments.
- Protocol version
- An immutable, approved set of eligibility criteria tied to a protocol document.
- Criterion
- One typed inclusion or exclusion condition with a source reference and computability.
- Dataset snapshot
- A loaded, queryable copy of an import. Cohort runs pin to a snapshot.
- Cohort run
- One deterministic evaluation of a protocol version against a snapshot on a run date.
- Potential match
- A record with no failing data-checkable criterion. Not an eligibility decision.
- Screening record
- A candidate in the screening workflow, with a site, reviewer, status and history.
- Recruitment event
- A milestone recorded by site staff — contacted, consent recorded, enrolled, withdrawn.
Three-valued evaluation
Each criterion evaluates to Met, Not met or Unknown. Screener-assessed criteria are Not evaluated against data. Missing data is never treated as Not met.