GUIDE

Case Report Form design checklist

Master the essentials of CRF design with this editable checklist

If you’re involved in CRF design, this essential resource leads you point-by-point through every consideration, helping ensure you’re on the right track for high quality, compliant Case Report Forms.

Why this checklist is a must-have

💡 Know the right questions to ask (what to include and what to leave out)

⚠️ Helps you prevent data entry mistakes

✅ Get your own editable checklist

Top 3 critical failures in CRF design

 Collecting unnecessary data (bloated forms cause confusion + delays)

❌ Unclear questions or fields, causing inaccurate & inconsistent data

❌ Poor layout or formatting – leading to data entry errors and delays in the review process

This resource tackles all three and provides a structured list to help you clarify intent, improve layout, and focus only on what’s needed. Simply complete the form to download your copy of the checklist.

What you’ll learn

Key questions to define before you start designing CRFs (so you capture only what the study needs)
Practical ways to avoid data capture errors and build quality into forms
Formatting essentials that reduce entry mistakes
Best practice for accurate layout
An editable document you can apply in design reviews today

About the author

Gilbert Hunter

Customer Success Manager

Gilbert Hunter, Customer Success Manager at Certara, leverages over a decade of experience in technical writing, professional services, and CDISC-based training to help organizations enhance clinical trial design and regulatory submissions. His focus is on enabling customers to overcome challenges and achieve their goals with greater efficiency and quality.

Download the checklist

Submit the form below to download your checklist and start designing high quality, effective CRFs!

About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

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