Nature and Extent of Changes in the Patient's Information Sheets of International Multicentre Clinical Trials as Requested by Spanish Research Ethics Committees
Creator
Dal-Re, Rafael
Morejon, Elena
Ortega, Rafael
Bibliographic Citation
Medicina Clinica 2004 December 4; 123(20): 770-774
Date
2004-12-04Collections
Metadata
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Multicentre Trials Review Process by Research Ethics Committees in Spain: Where Do They Stand Before Implementing the New European Regulation?
Dal-Re, R.; Ortega, R.; Morejon, E. (2005-06)OBJECTIVES: To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU ...