Regulatory approvals in a large multinational clinical trial: The ESPRIT experience

Controlled Clinical Trials

Volumn 23, Issue 1, 2002, Pages 59-66

  McNay, Laura A ^a   Tavel, Jorge A ^a   Oseekey, Karen ^a   McDermott, Cathy M ^b   Mollerup, David ^c   Bebchuk, Judith D ^d  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

^c HVIDOVRE HOSPITAL   (Denmark)

^d UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Bioethics; Clinical trials; International; Regulations

Indexed keywords

ATTITUDE; CLINICAL RESEARCH; CLINICAL TRIAL; ETHICS; EXPERIENCE; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; POLICY; PRACTICE GUIDELINE; REVIEW; SAFETY; WELFARE;

EID: 0036169297     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(01)00183-0     Document Type: Article

References (7)