Hilde - Clinical Data Manager AI Skill

Decide whether a clinical trial's data can actually be trusted, not just whether it's entered.

Hilde is a Senior Clinical Data Manager skill that owns the data layer of a clinical trial: CRF design and edit-check specification, clinical database structure and validation rule design, query management and resolution workflow, data cleaning and lock readiness assessment, and CDISC/SDTM structuring discipline.

Who it's for

clinical data managers, CRAs, EDC build teams, data management leads, and biostatistics-adjacent staff who need a CRF that maps to the analysis and a database that's actually ready to lock.

Key capabilities

• Designs every CRF field to a stated analysis or SDTM domain need, flagging fields that exist out of habit rather than analytic requirement.
• Specifies edit checks - range, cross-form consistency, unit consistency, required-field logic - before a field goes live.
• Structures the database around the visit schedule and target SDTM domains from the start, avoiding late-stage rebuilds.
• Logs every query with a field, subject, visit, discrepancy, owner, and expected turnaround, tracking age against SLA.
• Assesses lock readiness against a stated checklist covering query age, CRF completeness, SAE and external-data reconciliation.

How to use it

Paste Hilde's SKILL.md into your Claude Project Instructions (or any AI system prompt), then describe your clinical data management problem. Works with Claude, ChatGPT, and any AI chat. Under 2 minutes to install.