Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Author:

Kubiak Christine,de Andres-Trelles Fernando,Kuchinke Wolfgang,Huemer Karl-Heinz,Thirstrup Steffen,Whitfield Kate,Libersa Christian,Barraud Béatrice,Grählert Xina,Dreier Gabriele,Grychtol Ruth,Temesvari Zsuzsa,Blasko Gyorgy,Kardos Gabriella,O'Brien Timothy,Cooney Margaret,Gaynor Siobhan,Schieppati Arrigo,Sanz Nuria,Hernandez Raquel,Asker-Hagelberg Charlotte,Johansson Hanna,Bourne Sue,Byrne Jane,Asghar Adeeba,Husson Jean-Marc,Gluud Christian,Demotes-Mainard Jacques

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Reference10 articles.

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2. Directive 2001/20/EC of the European Parliament and of the Council of 4 April on the approximation of the laws, regulations and administrative provisions of the Member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal L. 2001, 121: 34-44.

3. Commission Directive 2003/94/EC of the 8 October laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Official Journal L. 2003, 262: 22-26.

4. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cell. Official Journal L. 2006, 294: 32-50.

5. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official Journal L. 2005, 91: 13-19.

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