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

4.2 Study Visits

4.2.1 Weekdays and Holidays

Sometimes we are so wrapped up in the day-to-day activities of conducting the clinical trial that we forget to perform some of the more obvious data checks. Data-cleaning activities that seem unlikely to bear fruit because “I can’t believe they would do this” or “there is no way they could mess this up” are always worth performing, especially when they are straightforward to implement. When someone fabricates or manipulates data, there are many aspects to consider so that the misdeed goes undetected; one detail may go overlooked or other facets may not even be considered! Consider, for example, the visit dates themselves. Sure, we may have validation checks to ensure that Visit (k-1) occurs before ...