Nature and Extent of Changes in the Patient's Information Sheets of International Multicentre Clinical Trials as Requested by Spanish Research Ethics Committees
Medicina Clinica 2004 December 4; 123(20): 770-774
Showing items related by title, author, creator and subject.
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 ...
Performance of Research Ethics Committees in Spain. a Prospective Study of 100 Applications for Clinical Trial Protocols on Medicines Dal-Re, Rafael; Espada, Julian; Ortega, Rafael (1999-06)OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one ...