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Table 4 Information sources, methods and outcome of B4 – eCRF design validation

From: EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach

Information source (S) Methods category (M) Outcome (O) Possible methodical approaches
Similar Medical Data Registry (MDR) Projects (B4.S1) Evidence-based Design of Electronic Case Report Forms (eCRFs) (B4.M1) Concrete eCRF Design (B4.O1) Qualitative Content Analysis [40]
Experts (B4.S2) Problem-Centered Expert Interview (B4.M2) Minimal Data Set (B4.O2) Qualitative Content Analysis