Combining Electronic Diary Seizure Data with Visit-Based Seizure Data in the MONEAD Study
Year of Publication
Skinner, Julia; May, Ryan
PharmaSUG 2018 US Conference
electronic data capture (EDC) system; Electronic diary (eDiary); Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD); mobile applications; seizure
Electronic diary (eDiary) mobile applications can be a useful tool to collect subject-reported data outside of scheduled study visits. However, integrating eDiary data with data stored in a traditional electronic data capture (EDC) system can present unique challenges. eDiary applications sometimes function under different business rules than traditional EDC systems. Collecting data in different software systems makes linkage of records more difficult, even if a common key exists. This paper describes methods used in the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study to combine daily subject-reported seizure data recorded in an eDiary application with clinically assessed seizure information collected in the study EDC system.