The importance of testing all aspects and features of a study before Go-Live cannot be over-emphasized. That being said, testing can be a very messy process. If not undertaken with a great deal of planning and documentation, the whole process of testing a study can be rendered not only ineffective but counterproductive. In comes User Acceptance Testing (UAT) to the rescue!
First, you might ask, what is UAT and how is it different from other forms of testing? Think of UAT as a dress rehearsal before a play. The actors all know their lines, the lighting director knows all their queues, and the sets have all been built and tested for safety. But you need to see it all together before you fill the seats with spectators. What if those perfectly built sets don’t line up with the spotlights or what if the bulky costumes get in the way of the actors’ performances? All the parts are there and accounted for, but the picture as a whole has yet to be validated.
The study-build process is similar. After each form has been tested separately, and all of the summaries and reports have been set up to your satisfaction, there is still the issue of unforeseen scenarios. You won’t be able to find or fix all the potential conflicts until you test the entire study as one. Set up a new site, enroll several patients, take each one through the entire screening/dosing/withdrawal/etc., process. Then do it again with another patient and another, until you have ironed out as many eventualities as possible. Even then, there may still be unforeseen problematic scenarios, but the purpose of UAT is to mitigate the number of issues that might come up during the Live study as thoroughly as possible. UAT is also a good way to provide you and your team with a finalized, succinct idea of what, exactly, you are signing off on before your sites begin entering patients. Once you complete your final run-through of the study, you can rest assured that you have done everything you can to make your study run smoothly.