Clinical Studies

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European Medicines Agency. Guideline on registry-based studies. Committee for Human Medicinal Products (CHMP). EMA/426390/2021

Published by European Medicines Agency

Feasibility AnalysisHuman Medicinal ProductsPatient RegistryReal Word DataReal World EvidenceRegistry-Based Study

The objective of this Guideline is to provide recommendations on key methodological aspects that are
specific to the use of patient registries by marketing authorisation applicants and holders (MAAs/MAHs)
planning to conduct registry-based studies

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Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (better known as Oviedo Convention) (Article 10)

Published by Council of Europe

BiomedicineHuman RightsPatients

It is a framework Convention aiming at protecting the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.

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Recommendation CM/Rec (2016)6 of the Committee of Ministers to member States on research on biological material of human origin

Published by Council of Europe

Biological Materials of Human OriginBiomedical ResearchGeneticsRights

Member States should protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity, the right to respect for private life and other rights and fundamental freedoms with regard to any research activity governed by this recommendation.

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