Matched to the protocol, not a template
Each form traces back to a specific protocol requirement — visit schedule, assessments, and endpoints — instead of a generic starting point that gets patched later.
What's included
What goes into the specification
- A form-by-form, field-by-field inventory mapped directly to protocol visits, assessments, and endpoints
- Field metadata — data type, format, controlled terminology, and units — defined to CDASH-aligned standards ahead of build
- Skip logic, branching, and visit-scheduling rules documented alongside each field so build has no gaps to interpret
- Annotations that trace each field forward to its SDTM domain, so mapping doesn't require re-deriving intent later
- Sponsor sign-off on the specification before a single screen is built in eCRF build
Ready for build and for analysis
Specifications carry through directly into eCRF build and are written with SDTM mapping already in mind.