validation-best-practices

What problem does it solve?

This Skill provides comprehensive guidance to validate SDTM datasets for FDA submission conformance, helping teams plan, document, and execute validation activities efficiently.

Core Features & Use Cases

• Guidance on validation workflows, cross-domain consistency checks, and compliance documentation (SDRG) across DM, DS, SV, VS, TS domains.
• Examples covering Pinnacle 21, CDISC CORE, Define-XML validation, and pre-submission SDRG rationale.
• Real-world use: a sponsor validates data before submission to ensure alignment with FDA requirements and CDISC SDTM standards.

Quick Start

Follow this guidance to design a validation plan for an upcoming SDTM submission. Run Pinnacle 21 or CDISC CORE to execute validations, compile the validation report, and document outcomes in the SDRG.