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EMA Questions and Answers about Raw Data Proof-of-Concept Pilot

This newly published European Medicines Agency ‘Questions and Answers Document’ provides answers to commonly asked questions about the proof-of-concept pilot on the submission and analysis of ‘raw data’ from clinical studies as part of selected initial marketing authorisation applications and post-authorisation applications submitted to the European Medicines Agency. The document relates to the ‘Information about the Raw Data Proof-of-Concept Pilot for Industry’. ‘Raw data’ means individual patient data from clinical studies in structured format from which statistical analyses are derived. Raw data includes the datasets in Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) formats.

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