Platform — private preview
Kyber Data Standards, in detail.
This page summarises what KDS covers and how it is built. Field-level definitions and crosswalk tables are not published here — they ship inside the versioned packs, available by request.
Resources, fields, codelists.
KDS defines the records a clinical-trial organisation keeps as typed resources, bound to codelists where a controlled value is expected.
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Level 1
156
Resources. The record types of clinical-trial operations — trackers, quality events, study data.
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Level 2
4,627
Fields. Typed, named and owned by one resource each, so every term in KDS means one thing.
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Level 3
915
Codelist files. Controlled vocabularies; 358 are pinned to an external terminology.
Crosswalk coverage
Fields pinned to each external standard, as a share of all 4,627 fields. Targets overlap.
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Any external standard815 · 17.6%
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FHIR R4751
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CDISC SDTM132
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CDISC Define-XML132
Bars share one scale: all 4,627 fields. We publish coverage as it stands, not as it will be.
Codelist terminology
Controlled values, not just field names, line up with external terminologies.
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Pinned to an external terminology358 · 39.0%
915 codelist files in total. The remaining codelists use KDS-local values.
Coverage, honestly stated. 88 resources are not yet externally mapped. Extending crosswalk coverage across the standard is on the roadmap now.
As of 4 October 2026. Source: KDS campaign at commit 33dc3b6. Machine-readable figures and provenance (stats.json).
The crosswalk model.
KDS is the operational vocabulary. External standards are targets a field is pinned to — not replacements for it.
- FHIR R4Exchange751fields pinned
- CDISC SDTMSubmission132fields pinned
- CDISC Define-XMLSubmission132fields pinned
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Pinned, not copied
Each mapping pins a KDS field to a named target in a specific standard. The KDS definition stays the source of truth.
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Many targets per field
A field can map to FHIR R4 for exchange and to SDTM and Define-XML for submission — which is why the counts overlap.
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Codelists too
358 of the 915 codelist files are pinned to an external terminology, so coded values line up as well as field names.
The tracker event taxonomy (v0.1 draft)
A hierarchical coding for quality and operational events, in the style of MedDRA's SOC and PT levels. Free text stays; a governed code is added, so events group, trend and surface recurrence.
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L1
Event Class ≈ MedDRA SOC
The shared QEO backbone. Ten classes that every tracker family codes against.
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L2
Event Category
Grouped areas within a class, defined per tracker family.
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L3
Event Term ≈ MedDRA PT
The specific event. Stable, hierarchical, never reused after retirement.
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The QEO backbone — ten L1 classes
Worded to mirror regulatory inspection-finding language.
DOCDocumentation & RecordsTRNTraining & CompetencyDATData Management & IntegrityPRCProtocol & Process DesignEQFFacilities, Equipment & MaterialsVENVendor & OutsourcingCOMCommunication & EscalationSYSComputerised SystemsSBJSubject Safety & ConductREGRegulatory Reporting
Seed families (v0.1)
Each tracker family adds its own L2 and L3 terms under the shared classes. The v0.1 seeds:
CAPA-Corrective & preventive actionsDEV-Deviations (non-protocol)PD-Protocol deviationsAUD-Audit findings
All seed vocabularies are under quality review before ratification.
Actual tracker content — demo study
What a tracker looks like
The complete CAPA tracker from Kyber’s demo study (fictional data), recorded exactly as the platform holds it — free text as written, with priority, status, owner and due date. The L2/L3 coding, full field list and crosswalk mappings are what ships in the packs.
| Entry | What happened (free text) | Priority | Status | Due | Owner |
|---|---|---|---|---|---|
CAPA-2026-001 |
ICF version control failure — site continued using outdated ICF version 2.1 after version 3.0 was approved | High | Closed | 2025-12-30 | Emily Foster |
CAPA-2026-002 |
AE grading error correction — PI graded AE as CTCAE Grade 2 instead of Grade 3 | Critical | Closed | 2025-12-15 | Rachel Adams |
CAPA-2026-003 |
SUSAR notification process delay | Critical | Closed | 2026-03-15 | Lisa Nguyen |
CAPA-2026-004 |
Informed consent timing violation | High | Closed | 2026-02-15 | Emily Foster |
CAPA-2026-005 |
SAE reporting delay — process fix in progress | Critical | In progress | 2026-04-15 | Rachel Adams |
One entry opened up — CAPA-2026-001
- Root cause
- Site staff not informed of new ICF version distribution.
- Corrective action
- Replaced all ICFs on site. Re-consented affected subjects.
- Preventive action
- Implemented ICF version acknowledgement tracker.
- Effectiveness criteria
- Zero ICF version errors in subsequent 3 monitoring visits.
Every tracker entry carries this structure — the demo study shown here is fictional; live trials never appear on this page.
MedDRA stays for safety. The taxonomy covers quality and operational events only. Adverse events keep MedDRA — this is never a parallel safety dictionary.
kds-packs.
KDS ships as versioned customer packs. Each build carries a SHA-256 integrity manifest, so contents can be checked file by file.
Pack access is by request. Packs are not available for direct download during private preview. Request pack access.
Pack figures come from the 29 September 2026 builds — an earlier snapshot than the coverage figures above.
| Pack | Version | Built | Files | Size | Integrity | Access |
|---|---|---|---|---|---|---|
| KDS-v0.1-CUSTOMER-PACK | 0.1 | 29 Sep 2026 | 2,419 | 18.2 MB | SHA-256 manifest | Request pack access |
| KDS-v0.1.0-CUSTOMER-PACK | 0.1.0 | 29 Sep 2026 | 2,419 | 18.2 MB | SHA-256 manifest | Request pack access |
What a pack contains
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conformance/1,161 Conformance rules with positive and negative test fixtures -
codelists/902 Codelist schemas and the controlled-terminology registry -
crosswalks/216 CDISC and FHIR crosswalk documents -
trackers/123 Tracker workbook templates -
docs/ schema/ traceability/ registry/ + licence17 Start-here guide, playbook, release notes; database schema and validation engine; KDS-to-SOP traceability; registry and validation; licence terms