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EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources

What is Metadata?

A set of data that describes and gives information about a dataset. More specifically, information describing the generation, location, and ownership of the data set; key variables; and the format (coding, structured versus not) in which the data are collected is needed to enable accurate identification and qualification of the exposure and outcome information available.


Metadata also includes the provenance and time span of the data, clearly documenting the input, systems, and processes that define data of interest. Finally, metadata includes details on the storage, handling of processes, access, and governance of data.


The Good Practice Guide aims to provide recommendations for the use of the EU metadata catalogue to identify real-world data sources suitable for specific research questions and to assess the suitability of data sources proposed to be used in a study protocol or referred to in a study report.


A data source is a data collection (or a set of linked data collections) sustained by a specified organization, which is the data holder. It is characterised by the underlying population that can potentially contribute to records, the event triggering the creation of a record in the data source and the data model.


Click this LINK to know more about how to use the Metadata Catalogue of Real-World Data Sources.

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