Article

Ethical and Procedural Issues For Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside The European Union: The Challenging Experience of The DEEP Project

2021-02-17

Abstract excerpt

<h4>Background: </h4> . We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512).This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Compet...

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Literature Corpus work: a6e7e454-cb1f-58aa-b442-e33b842ef22f
DOI: 10.21203/rs.3.rs-200496/v1

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Ethical and Procedural Issues For Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside The European Union: The Challenging Experience of The DEEP ProjectDOI 10.21203/rs.3.rs-200496/v1Read

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