Agreed before data starts flowing
Format and timing are settled with every external vendor up front, avoiding rework once transfers are already underway.
What's included
What the specification defines
- Every external data source identified — central lab, ECG, imaging, IRT, or other vendor feed — with a named owner on each side
- File format, transfer frequency, and delivery mechanism agreed and documented for each feed
- Field-level mapping between the vendor's data structure and the study database, reviewed against the eCRF/aCRF specification
- Handling rules for missing, duplicate, or late-arriving records defined up front rather than improvised mid-study
- Version control so any amendment to a feed's structure is tracked and re-agreed before it takes effect
The spec behind every import
Directly governs data import setup and validation, so what's built matches what was agreed.