Learn how to build error-free Define.xml packages that speed regulatory review and avoid common pitfalls

This practical checklist gives clinical programmers and submission teams the step-by-step guidance needed to prepare a complete and compliant Define.xml file for regulatory submissions.

Why this checklist is a must-have:

✅ Essential checklist items for every stage of Define.xml prep
✅ Sets out how to avoid common mistakes that slow review cycles
✅ Practical do’s and don’ts to improve clarity and reviewer usability
✅ Learn and apply best practices that align with regulatory expectations

Top 3 critical failures this checklist helps you avoid:

❌ Incomplete or inconsistent metadata (e.g. missing variable definitions, incorrect controlled terminology, or discrepancies between datasets and XML)
❌ Unclear, poorly structured codelists or derivation documentation
❌ Missed final validation and QC checks, leading to submission errors and delays

This checklist addresses these knowledge gaps and provides a practical, regulatory-informed set of steps to follow – from compiling accurate metadata to final QC validation and preparation of submission deliverables. Complete the form now to download your copy ➡️

What you’ll learn with this checklist:

• How to prepare a complete and compliant Define.xml metadata file
• How to validate metadata consistency across datasets and XML
• How to clearly document derivations and Controlled Terminology
• How to accurately prepare a compliant, submission-ready package

Submit the form now to download your checklist and become an expert in creating compliant Define.xml.

About the author

Trevor Mankus
Product Manager

As a Product Manager at Certara, Trevor Mankus helps deliver value to customers via improvements to Pinnacle 21 software. Trevor identifies problems and opportunities and then directs our engineering R&D efforts at these areas to help create the most value — optimizing complex trade-offs in the process. Product managers sit at the intersection of business, UX design, and technology. Prior to his time at Certara, he enjoyed working in the healthcare industry at various Pharmaceuticals and CROs as a clinical programmer.

Trevor has been an active CDISC member since 2009 focusing primarily in the ADaM project. He was selected to be the future CDISC ADaM team lead (2026-2027) and has been co-leading the CDISC ADaM Conformance Rules sub-team for many years. Notable accomplishments include multiple publications of the CDISC ADaM conformance rules catalog.