Differences in clinical trial conduct in US and EU investigational sites

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.