Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

2.2 Risk Indicators

2.2.1 Individual Risk Indicators

2.2.1.1 Risk Indicators from CDISC-Formatted Data Sets

In the very near future, CDISC-formatted data sets will be required for regulatory submissions to the U.S. Food and Drug Administration [14,15]. While it is entirely possible for a company to maintain its pre-CDISC standards and map its data to SDTM prior to submission, this is a shortsighted strategy. Most important, there are very real concerns that there could be differences between analyses based on sponsor- versus CDISC-standard data sets due to difficulties in mapping between the two. Depending on the severity of the problem, this may cause delays in the regulatory submission or review. It is much more straightforward and efficient ...