Validation, Publication, and Maintenance of real-world data sources and studies in the HMA-EMA RWD Catalogues

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The purpose of this SOP is to describe the steps and procedures concerning the validation, publication, and maintenance of data sources and studies within the HMA-EMA Catalogues of real-world data (RWD) sources and studies. The principles and activities described will apply specifically to EMA staff responsible for the validation of the Catalogues’ content. The same principles will apply to the Catalogues’ users when submitting entries.

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European Medicines Agency (EMA)

Year of publication

2025

ISBN

SOP/TDA/3543; EMA/467789/2024

Source

European Medicines Agency (EMA)

Author

European Medicines Agency (EMA)

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