Sponsored clinical trials have monitors who make sure that the primary data are collected and recorded properly. They meet periodically with research coordinators and review their study records. They ensure that the reporting of adverse events is complete. This very useful auditing function serves to promote Good Clinical Practices and to enhance the compulsive collection of data. It is required by the FDA, which does not like to review incomplete studies. These monitors do not relate to the subjects. Within the framework of Workspace, the Data Cleansing Zone provides the support for the Monitors.


Reference: ori.hhs.gov/education/products/ucla/chapter5/default.htm
Source: NFU - D4LS versie 0.8 van 26-10-2016 
0.1 5/23/17 ​


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