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Guideline on registry-based studies

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Guideline on registry-based studies - launch of public consultation

EMA has published its draft Guideline on registry-based studies for a three-month public consultation today. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence.

Patient registries are databases containing quantitative and qualitative data about patients who are affected by a particular condition.

The guideline addresses methodological, legal and operational aspects in the use of registry-based studies to support regulatory decision-making.

Stakeholders are invited to send their comments via an online form by 31 December 2020.

More information: https://www.ema.europa.eu/en/news/guideline-registry-based-studies-launch-public-consultation

Who should register?

Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.

Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.