Clinical Monitor

Clinical Monitor was built as a demonstration system to teach new auditors how to monitor a human clinical trial of a new drug. Doing these trials requires a great deal of paperwork that is audited on a monthly basis by field agents (called ``clinical monitors'').

  

Figure 2.27: Clinical Monitor's title screen.

40#40

In Clinical Monitor, students take the role of a field auditor who is going to a trial site in its first few weeks of a study of a new heart medicine. Students are told by a coworker that they will be in charge of a subset of the documentation to look for three kinds of errors: the testers have failed to report a serious adverse event (such as angina), the testers have failed to follow the protocol of the test (such as including a patient who has a history of heart problems), or the testers have made a minor mistake (such as copying a date from one form to another incorrectly).

Unlike the previous INDIE applications, students aren't collecting the data directly in this project. Instead, the data has been previously collected and they are in charge of deciding what it means. Students sort through the notebooks and drag any part of the forms they feel is in error into one of three categories of case notebooks.

  

Figure 2.28: Examining the books in Clinical Monitor. Students drag information from the spiral notebook into the tabbed notebook on the lower left.

41#41

When they feel they have found all the mistakes (not finding mistakes in a trial like this turns out to be either a sign of bad auditing on the monitor's part or a sign of fraud on the part of the doctors running the clinical trial), they submit their work to a coworker. He comments on the mistakes they've made, including miscategorized errors or errors that aren't actually errors. He doesn't let students continue until they have found some large minimum number of the errors.

Once the coworker is satisfied, the students get a glimpse of what their parent organization would have to say about their work a few weeks later when the data is more thoroughly analyzed. Here, students hear about errors they've missed, meaning students have a two-stage remediation phase. From there, students continue on to the next site to do more audits.

Clinical Monitor is the least like other INDIE projects--the testing phase is reduced to sifting through documents, while the remediation comes in two different parts, and no overall claim is being made about the case outside of ``There are mistakes here.''