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Clinical Trial Directive 2001/20/EC Public Consultation 2009/2010 Comments from EURO EU CRO Federation 08 January 2010Name of Organization EURO European CRO Federation Secretariat 60, Rue Carnot F92100

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What is clinical trial directive 20ec?

Clinical trial directive 20ec is a directive of the European Union that provides a regulatory framework for the conduct of clinical trials in the European Union member states.

Who is required to file clinical trial directive 20ec?

Sponsors or investigators conducting clinical trials in the European Union member states are required to file clinical trial directive 20ec.

How to fill out clinical trial directive 20ec?

The process of filling out clinical trial directive 20ec involves providing detailed information about the trial, including the study design, objectives, methodology, participant eligibility criteria, safety measures, and reporting requirements. This information must be submitted electronically through the European Union Clinical Trials Register (EUCTR).

What is the purpose of clinical trial directive 20ec?

The purpose of clinical trial directive 20ec is to ensure the safety and efficacy of clinical trials conducted in the European Union member states, protect the rights and welfare of trial participants, and facilitate the harmonization of clinical trial regulations across member states.

What information must be reported on clinical trial directive 20ec?

Clinical trial directive 20ec requires the reporting of information such as the trial protocol, investigational medicinal product details, participant recruitment process, adverse event reporting procedures, and trial results.

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