Agent_skills clinical-trial-schema-designer

name: clinical-trial-schema-designer version: 1.0.0 description: Analyzes clinical trial protocols and generates CDISC-compliant (SDTM/ADaM) data schemas. Use when designing data ingestion pipelines for clinical research or preparing regulatory submissions. inputs: protocol_text: type: string description: The raw text of the clinical trial protocol. required: true target_standard: type: string enum: [SDTM, ADaM, CDASH] default: SDTM outputs: schema_definition: type: object description: The generated data schema in JSON format. mapping_logic: type: array items: type: string capabilities:

• Study variable extraction (Demographics, Adverse Events).
• Automated CDISC domain mapping.
• Pydantic/SQL schema generation. constraints:
• Accuracy depends on protocol text quality.
• Custom designs may require manual refinement. security:
• Protocols are intellectual property; process securely.
• Does not handle actual patient results. examples:
• input: protocol_text: "Study will track heart rate daily..." output: schema_definition: domain: "VS" variables: ["VSTESTCD", "VSORRES"] mapping_logic: ["Map 'heart rate' to VSTESTCD='HR'"]