CRFs that map to SDTM — by construction.
Asthra drafts CDISC CDASH–aligned Case Report Forms from your protocol, domain by domain. Field names and controlled terminology are chosen to map cleanly to SDTM — so the bridge from clinical data capture to submission datasets is built in, not bolted on.
What you bring to the draft.
Asthra derives the form set from your study design and your data standards.
Trial Protocol
Visit schedule, assessments, and the safety monitoring plan — the basis for the schedule of assessments and every domain.
CDASH Implementation Guide
Standard field names, data types, and controlled terminology applied as the authoring ruleset.
SDTM Mapping Spec
The target submission model. Asthra chooses CRF fields that map cleanly downstream.
Sponsor Data Standards
House conventions and EDC system specifications, so the forms fit your capture environment.
Prior Study CRFs
Optional. Used for consistency and to avoid fields that historically generated queries.
TA Supplemental Guidance
Therapeutic-area domains and fields beyond the core CDASH set.
From protocol
to an SDTM-ready CRF.
Upload & classify
Drop your protocol, CDASH guide, SDTM spec, and data standards into the project. Asthra extracts the visit schedule and the required assessments.
Approve the plan
Asthra proposes the domain set, the schedule of assessments, and the field-to-SDTM mapping. Edit, add TA-specific domains, approve once.
Generate the first draft
Asthra drafts each domain with CDASH field names and controlled terminology, with completion guidelines. Gaps flag where a protocol assessment lacks a capture form.
Writer review in Word
Refine fields, tighten completion instructions, or check SDTM mappability in the task pane. Every change is logged.
Hand off to EDC build
The form set ships with the audit ledger embedded and a clean field-to-SDTM map — ready for the EDC build with fewer downstream queries.
What changes for the data management team.
Manual CRF design
- −CDASH field names looked up and applied by hand, domain by domain
- −SDTM mappability checked after the fact, forcing rework
- −Schedule of assessments reconciled against the protocol manually
- −Over- or under-collection discovered only when queries pile up
- −Consistency with prior studies depends on tribal knowledge
CRF design with Asthra
- +CDASH field names and terminology applied as a ruleset
- +Fields chosen for clean SDTM mapping from the start
- +Schedule of assessments derived directly from the protocol
- +Each form traces to the protocol assessment it captures
- +End-of-run QC confirms CDASH conformance before the EDC build
Pilot Asthra
on a real CRF.
30-day pilot. Bring one protocol. We'll match Asthra's CDASH-aligned CRF against your existing process — domain by domain.