Abstract
Quality systems designed to prevent and detect the occurrence of fraud by clinical investigators are proposed and discussed. These include better selection of investigators at the prestudy stage and the systematic review of documents and data generated by both investigators and patients, together with a critical appraisal of the way in which supplies of medication have been handled; careful monitoring of the relative rates of patient recruitment between investigators in multi-center studies is also suggested.
The need for clinical trial monitors to develop a frame of mind that permits a healthy level of scepticism to be applied in anomalous or suspicious situations is discussed and the importance of standardization of data monitoring techniques and of continuous training on quality issues for all who are involved in the clinical research process are also emphasized.
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