Open AccessDifferences in clinical trial conduct in US and EU investigational sites
Author(s) -
Mackintosh Douglas R.,
Molloy Vernette
Publication year - 2001
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.126
Subject(s) - clinical trial , audit , business , quality (philosophy) , accounting , member states , clinical practice , compliance (psychology) , medicine , subject (documents) , family medicine , psychology , library science , computer science , european union , social psychology , philosophy , epistemology , economic policy
Observations by clinical auditors about good clinical practice (GCP) compliance in US and EU investigational sites are described. Specific differences between the two regions are noted for institutional review boards (IRBs) and ethics committees; subject recruiting and consenting; investigator/study coordinator qualifications and functions; organization and recording of source data; health care delivery; quality of monitoring; and filing of regulatory documents. Neither region of the world demonstrated GCP superiority in the conduct of its clinical trials. Copyright © 2001 John Wiley & Sons, Ltd.