EMA - Questions and Answers about the raw data proof-of-concept pilot for industry

10th May 2023

EMA - Questions and Answers about the raw data proof-ofconcept pilot for industry
Scope, terms of participation and data submission process

This document provides Answers to commonly asked Questions about the proof-of-concept (PoC) pilot
on the submission and analysis of ‘raw data’ from clinical studies as part of selected initial marketing
authorisation applications (iMAAs) and post-authorisation applications submitted to the European
Medicines Agency (EMA). This Questions and Answers document relates to the ‘Information about the
raw data proof-of-concept pilot for industry’.

‘Raw data’ also referred to as ‘Standardised Study 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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