An Introduction to CRF Annotation in Clinical Trials [Video]

Learn how annotated case report forms create a clear line from site entry to reviewer-ready datasets—so every value is traceable, standardised, and fit for analysis.

In this explainer, we define what an annotated CRF is and why it matters for data integrity, compliance, and submission readiness. You’ll hear how to use CDASH at collection and map cleanly to SDTM for tabulation, what to include in each annotation—domain, variable, units or codelists, and brief derivation notes—and how to divide detail between the aCRF and programming specifications. We walk through a practical build workflow from protocol objectives to cross-functional review and controlled versioning, plus how to manage amendments without breaking traceability. We also cover integrating external sources such as labs, devices, and apps, and share quick tips and common pitfalls to avoid, including uncontrolled terminology, unclear conditional logic, and releasing EDC builds without an approved aCRF.

At Quanticate, our biometrics teams help sponsors design, review, and maintain aCRFs that align with standards and downstream analysis—reducing queries and smoothing the path to submission. Submit an RFI today.