By Emily Cantrell, Senior Director Operations and Becky Baggett, Senior Project Manager, Rho
Depending on your phase of development and the type of data you are collecting, validation may be required. The first question you should ask is “what stage of development are you in?” If you are using ePRO for a pivotal trial or the data is likely to be used in a marketing application submission like an NDA, it is highly likely validation is necessary. On the other hand, if you are collecting data through ePRO for an early phase exploratory study, it may not be required. The second question you should ask is “will ePRO be used to record my primary endpoint?” If the answer is yes, it is likely that validation is necessary. If not, it may not be necessary depending on what data will be collected and how it will be used.