CDISC SDTM Mapping Starts at Study Build — Not at Data Lock
The Trialhelix data management module runs SDTM variable mapping in parallel with EDC data collection — so your team arrives at data lock with domain structures already drafted and reviewed, not starting from scratch.
Data Cleaning at the Speed of the Study
Query cycle time is one of the most controllable variables in clinical data management. The Trialhelix data management module reduces query volume by catching issues at data entry (edit checks) and reduces resolution time by making query assignment and response workflows explicit.
- Automated query generation from edit check failures — no manual review required
- Query routing by site, form, and CDM assignment
- Query aging tracker — days open per query type and severity
- Resolution workflow with reason-for-change capture and CDM approval
- Query summary report for sponsor data review meetings
SDTM Domains Covered
Trialhelix generates SDTM domain mapping for the standard Phase I/II dataset classes. Additional domains can be configured for studies with specialized endpoints.
Demographics & Disposition
DM, DS domains. Subject disposition events — screen failure, early termination, completion — mapped to SDTM DS from eCRF disposition forms.
Adverse Events & Medical History
AE, MH domains with MedDRA coding. CTCAE grading captured at entry. AE-to-TEAE classification rules configured per protocol SAP.
Laboratory & Vital Signs
LB, VS domains. Lab units normalized per CDISC controlled terminology. Normal ranges tracked per visit and flag derivation rules applied to generate LBNRIND and VSNRIND.
Exposure & Pharmacokinetics
EX, PC, PP domains. Dose exposure linked to IWRS assignment. PK sampling windows configured per SAP. NCA-derived parameters mapped to PP with analysis method footnotes.
Concomitant Medications
CM domain. WHODrug coding integration with verbatim term mapping workflow. Prior and concomitant medication classification rules per protocol window definitions.
Findings About Events
FA domain for structured data associated with other domains. Protocol deviation coding against study-specific deviation taxonomy. SE domain for serious event classification.
Continuous SDTM Validation — Not Just at Data Lock
Pinnacle 21 compliance validation is typically run once — at data lock, when fixing issues is expensive. Trialhelix integrates Pinnacle 21 checks as a continuous validation step during data collection, so SDTM conformance issues are caught while the study is running.
When a new SDTM domain is drafted, a validation report is generated automatically. The CDM team sees which variables fail conformance checks before any data lock decision is made. Validation report history is retained as part of the study audit trail.
- Pinnacle 21 Community and Enterprise both supported
- Validation runs triggered automatically on domain updates
- Suppression rules (suppress, justified deviation) tracked with reason
- Reviewer's guide generation for FDA submission packages
See SDTM Mapping on Your Endpoints
Bring your SAP and we will walk through how the data management module maps your specific endpoints to CDISC SDTM and ADaM structures — including any unusual domains your study requires.