The Impact of Standardized eCRFs from Data Collection to Submission

Programmers, how often have missing or incorrect annotations delayed your creation of mapping specs? And how controlled are those controlled terminologies, anyway? If the burden of mapping, creating, and validating data sets only seems to be growing, it’s because it is.

These two sets of problems share a common source: non-standardized electronic case report forms (eCRFs). Since the advent of web-based electronic data capture (EDC) 30 years ago, the profusion of EDC systems and new data types have forced data managers to create untold versions of thousands of forms. Meanwhile, clinical and statistical programmers struggle to map source to SDTM, as they piece together what a given name, label, and value means for each study (or worse, each form). The result? Costly delays at every step of the data journey, from collection to submission.

There’s a better way. By leveraging your own “metadata workbench,” it’s now possible to assemble standardized eCRFs and visit schedules almost as easily as snapping together Lego bricks. Join us to explore the advantages of this approach. We will cover:

• The importance of CDISC and proprietary standards
• Standardizing content across EDC systems
• Automating annotation for submission-ready CRFs
• Maintaining version control
• Fostering collaboration between programmers and data managers at the point of form and study creation

We’ll explore a no-code solution that lets you preview and build eCRFs for 9 common EDC systems from one template. Finally, we’ll share how Biogen realized cost and time savings with this approach to standardization and version control.

Ready to mobilize your metadata for faster and more accurate data flow? Let us show you how.