Apply CDISC SDTM and ADaM standards to regulatory submissions.
npx skills add https://github.com/awslabs/hcls-agent-skills --skill cdisc-compliance
Please help me install this Agent Skill. Skill: cdisc-compliance Source: https://github.com/awslabs/hcls-agent-skills/tree/main/skills/cdisc-compliance Command: npx skills add https://github.com/awslabs/hcls-agent-skills --skill cdisc-compliance
This skill resolves the complexity of aligning clinical trial data with CDISC SDTM and ADaM standards, preventing costly regulatory submission delays and P21 errors.
Invoke the cdisc-compliance skill to review the mapping logic for your oncology tumor assessment domain and ensure it meets current FDA submission standards.
High-intent search queries and answers about installing and using this skill.
To resolve Pinnacle 21 errors for FDA submission datasets, use this skill to systematically triage data queries based on clinical impact and safety significance. It provides decision frameworks for troubleshooting compliance issues during final clinical study submission stages.
Mapping clinical trial data to CDISC SDTM domains requires expert reasoning for complex domain mapping and SUPPQUAL usage. This skill provides regulatory decision support to align your raw clinical data with current FDA and PMDA submission standards.
Generating define.xml metadata for FDA submissions requires applying CDISC controlled terminology versioning and traceability rules. This skill offers expert guidance on define.xml metadata requirements to ensure regulatory submission data integrity.
Yes, you can validate ADaM dataset design against PMDA compliance standards. This skill applies CDISC ADaM implementation rules to verify traceability and controlled terminology versioning for both FDA and PMDA regulatory submissions.
Use SUPPQUAL domains instead of standard SDTM variables when handling non-standard data that cannot fit into existing CDISC domain structures. This skill provides decision frameworks for complex domain mapping and SUPPQUAL usage in regulatory submissions.
Controlled terminology versioning causes CDISC compliance failures when dataset mappings use outdated or mismatched terminology codes. This skill ensures correct terminology versioning and traceability across SDTM and ADaM datasets to maintain regulatory submission data integrity.
RConsortiumConvert raw EDC/eCRF clinical data into CDISC SDTM domains.
mark64oswaldGenerate regulatory-grade synthetic clinical trial data across SDTM domains.
89jobrienAudit web content for WCAG 2.1/2.2 conformance and accessibility issues.
jorgealvesTranslate clinical protocols into CDISC-compliant SDTM/ADaM data schemas.
