Common problems can have major consequences

January 2009
Clinical Trials Administrator;Jan2009, Vol. 7 Issue 1, p5
The article presents tips and strategies from Jan Hewett, director of the University of Michigan Medical School institutional review board (IRB) in Ann Arbor, Michigan, to prevent problems that could be created by non-compliance with regulations. Hewett stresses the need of the investigator to know about the IRB. An example of how a well-intentioned clinical trial (CT) change can have a little effect because of noncompliance is presented. Hewett suggests ways to educate investigators and to answer questions as they complete the protocol application.


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