EMA's Q&As on Raw Data from Clinical Trials

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The European Medicines Agency (EMA) issued an updated Questions and Answers (Q&A) document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry.

What is Raw Data?

In this context 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.

Will the Raw Data Analysis lead to more GCP Inspections?

According to the Q&A paper, visualization and analysis of raw data will be used to support the benefit-risk assessment of the regulatory procedure. For some procedures the raw data will be used to support the selection of sites for Good Clinical Practice (GCP) inspections. However, "participation in the PoC pilot will not per se increase the number of sites selected for the routine GCP inspections programme", the agency says. All clinical trials that are part of a marketing application dossier could merit closer scrutiny, e.g. by an inspection. Thus, the data analyses will (only) support the decision-making process in regard of the selection of sites for GCP routine inspection.

More information is available in the Questions and Answers about the raw data proof-of-concept pilot for industry published on the agency´s Big Data website.