OBJECTIVES: Healthcare decision makers are increasingly requesting health economic (HE) data, both to support product approval and for marketing purposes. Currently, there is limited information available to aid decisions surrounding the clinical monitoring of HE endpoints when they are collected as part of a clinical trial.  It is necessary to understand the current level of monitoring activities surrounding HE data and evolve best practices for monitoring such data.   METHODS: To better understand monitoring activities, a literature review was performed and qualitative in-depth interviews were conducted with six clinical research associates (CRA) who had experience collecting HE data as part of clinical trials in a range of therapy areas.  The literature review and interviews focused on understanding current clinical trial monitoring practices, monitoring activities specific to HE data, the challenges faced during monitoring and recommendations for the future. RESULTS: All CRAs interviewed reported working either with patient-reported outcome (PRO) measures – quality of life questionnaires, patient diaries -- and/or healthcare resource utilization data, in different therapy areas.  Data monitoring activities in clinical trials can include a number of specific tasks ranging from full source data verification (SDV) to partial SDV to just checking for accuracy, legibility and completeness.  The most common challenges in monitoring of HE data included incomplete questionnaires, misinterpretation of questionnaire data by the sites, and difficulty in SDV of healthcare resource utilization data by the CRA.  Recommendations for the future included optimizing methods for documentation of healthcare resource utilization data, improving patient/site training in PRO use, and selecting the type of PRO and mode of PRO administration based on the patient population being examined. CONCLUSIONS: Health economic endpoints are increasingly being used in clinical trials, and CRAs are becoming familiar with PRO and healthcare resource utilization data.  Monitoring activities for HE data vary by the study design and type of data collected.