H1ST-AI-DBD-001 · Task 1.5
SDTM shouldn't be a downstream scramble
When mapping is disconnected from design, conformance becomes something you chase instead of something you have. The SDTM Annotation Agent maps CRF fields to SDTM domains and variables automatically, produces the annotated CRF and Define.xml, and validates against SDTM IG v3.4 — so submission mapping is built in at design time and arrives Pinnacle 21-clean, not bolted on and reworked later.
The grind you know
By the time SDTM mapping lands on your desk, the CRF design that shapes it is long finished — so you're reverse-engineering conformance the design should have carried from the start. Annotating CRFs and hand-building Define.xml is slow, exacting work, and the findings that surface here trace back to decisions made weeks ago, when they would have been easy to fix.
Part of the Database & Forms Design family
Protocol to CRF, ICF, SDTM & coding.
When mapping is disconnected from design, conformance becomes something you chase instead of something you have. The SDTM Annotation Agent maps CRF fields to SDTM domains and variables automatically, produces the annotated CRF and Define.xml, and validates against SDTM IG v3.4 — so submission mapping is built in at design time and arrives Pinnacle 21-clean, not bolted on and reworked later.
The agent takes the CRF fields and study standards as input.
Fields are mapped to SDTM domains and variables with controlled terminology applied.
It outputs the annotated CRF and Define.xml and validates clean in Pinnacle 21.
Capabilities
Maps CRF fields across all 35+ SDTM domains (DM, AE, CM, LB, VS, EG, and more) with ML-based field matching.
Generates the annotated CRF and a Define-XML v2.1 file conforming to the CDISC standard, with variable attributes and origins.
Integrates CDISC controlled terminology packages and manages study-specific extensions.
Validates annotations against SDTM IG v3.4 rules through Pinnacle 21 so mappings are conformant before data flows.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
By the time SDTM mapping reaches you, the CRF design that shapes it is long finished and you are reverse-engineering conformance. The agent maps CRF fields to SDTM domains at design time, so the annotation is built in rather than reconstructed weeks later.
Hand-assembling Define.xml with variable attributes, origins, and derivations is exacting, slow work. The agent generates the annotated CRF and a conforming Define-XML v2.1 file together, with controlled terminology applied, so you review rather than build from scratch.
A conformance finding at submission time traces back to a mapping decision made weeks ago, when it would have been cheap to fix. The agent validates annotations against SDTM IG v3.4 through Pinnacle 21 before data flows, so mappings arrive clean instead of needing rework.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Pinnacle 21
Validation
Gemini / Anthropic LLM
LLM
Who it's for
Turns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
Learn moreTransforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Learn moreGenerates complete, conformant Define-XML v2.1 metadata and the accompanying Reviewer's Guide directly from your SDTM and ADaM datasets.
Learn moreRuns Pinnacle 21 conformance validation on your SDTM and ADaM datasets and explains every finding in plain, actionable language.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
