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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