Monitoring program finds common mistakes

January 2009
Clinical Trials Administrator;Jan2009, Vol. 7 Issue 1, p7
The article discusses the importance of a post-approval monitoring program of the University of Virginia in Charlottesville, Virginia in identifying the clinical trial (CT) compliance deficits and other trends. Common mistakes of investigators and CT staff which are identified by the post-approval monitoring process include failing to obtain two parent/guardian signatures, confusion about privacy plans, and enrolling subjects in more than one protocol. Questions given for CT staff and investigators are listed.


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