Expand your knowledge with the ultimate best practice guide to automating CRF annotations
If you’re involved in CRF annotations, don’t miss this opportunity to broaden your expertise and master the essentials of automating annotated CRFs (aCRFs) with this comprehensive guide.
Why this guide is a must-have:
💪 Learn exactly what the FDA expects to see in your annotated CRFs
⚠️ Teaches you the do’s and don’ts of how annotated CRFs should be prepared, formatted, and submitted
💡 A key step in understanding how CRF annotations can be automated across trials
Key critical failures when preparing and submitting annotated CRFs include:
- Lack of sufficient knowledge around specific FDA formatting requirements, including:
- The color of CRF annotations
- The placement of annotations
- The use of fonts
- Poor understanding of submission requirements – particularly in terms of PDF specific contents, functionality, and linking
This guide addresses these knowledge gaps and puts you in the strongest position for successfully preparing and submitting annotated CRFs. Simply complete the form to download your copy of the guide.
What you’ll learn in this guide:
- How to meet FDA requirements for CRF annotations
- How to avoid common mistakes when formatting CRF annotations
- How to avoid common PDF submission errors
- How to adhere to CDISC SDTM metadata submission guidelines
Submit the form now to get your hands on this essential guide ➡️
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.
