Designing Variables and Case Report Forms (CRFs)

Before any software, a good electronic form is a good design on paper. This level teaches the tool-agnostic craft of planning what to collect, naming and coding variables consistently, and designing a case report form that mirrors your protocol and prevents errors at the source.

Who this level is for

Data managers, coordinators, PIs and anyone who designs case report forms. Recommended after Level 1.

What you'll learn

• How to plan data collection from your hypothesis and sampling plan: what data, how, and on which devices
• Best practices in variable design: collect the minimum necessary, use consistent coding (for example Y/N = 1/0), and keep a variables table
• What the assure and describe phases mean: quality checks, double entry, range checks, data dictionaries and codebooks
• The principles of good CRF design: align with the protocol and analysis plan, logical order, grouped items, clear instructions
• Variable naming, coding and metadata: short names, defined formats, units and allowed ranges
• Validation rules, skip patterns and calculated fields as concepts, before you build them in a tool

You finish with: Your variables table + a CRF design for one key form.