REFLECTION PAPER Final
Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools
ABSTRACT — EDITORS' SUMMARY
EMA expectations for eSource and EDC. Predates the 2023 Computerised Systems guideline; still cited for design principles around data origination.
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PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-expectations-electronic-source-data-data-transcribed-electronic-data-collection_en.pdf ↗ RELATED · SAME AUTHORITY