Writing rules, edit checks, and their correlated test scripts is the most time-consuming part of building the study database in an Electronic Data Capture (EDC) system. Veeva is transforming the build process with an advanced study design environment where users configure most edit checks and use a powerful rules engine when creating rules and advanced checks right within the system, rather than outside of it. Perhaps the biggest advance is Veeva’s progress toward eliminating the need for custom functions.
Terminology can vary by organization, therefore for clarity, it is important to level-set on the nomenclature used in this paper. Edit checks are logical tests applied to fields in the electronic case report form (eCRF) for the purpose of catching errors and improving data accuracy. Derivations use existing data to calculate a related value, such as using height and weight to calculate BMI. Derivations save time by automating calculations and reducing manual data entry. Rules and dynamics provide automation by performing actions such as sending emails, adding forms to visits, or displaying invisible fields. Custom functions are pieces of code written outside of the EDC and inserted into the system to perform an intended action.
Traditional EDC systems were developed years ago when clinical trials were more straightforward but with increased complexity in trial designs, now tend to require many custom functions to augment their functionality. Many standard rules, such as sending configurable emails, as well as cross-form edit checks and derivations require custom functions. Because most custom functions are written in C# or SQL, firms need to hire expensive software engineers with traditional programming skills and training.
Learn how companies like ICON, Alcon, and Bioforum – The Data Masters are building edit checks directly within the EDC, eliminating the need for custom functions. With the powerful rules engine in Vault CDMS, these companies are speeding clinical trials and supporting greater agility during study conduct.