CT directors should take steps to manage risk

June 2010
Clinical Trials Administrator;Jun2010, Vol. 8 Issue 6, p68
The article reports that clinical trial (CT) directors are obliged to handle problems with regard to risks in human subjects research. Barbara M. Longmire, director of the office of clinical trials at the University of North Carolina at Chapel Hill in Chapel Hill, North Carolina, cites the factors to be considered when negotiating a contract with a sponsor. She suggests ways of managing risks in CT such as making sure that the sponsor has insurance and reviewing contract language and informed consent documents for inconsistencies.


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