OBJECTIVES To provide an overview of considerations sponsors/vendors need to address in order to meet FDA expectations during the planning and implementation phases when using Electronic Patient-Reported Outcomes (ePROs) in clinical trials, to understand important considerations required in ePRO-use when planning and implementing clinical trials, identify essential considerations from a vendor's perspective, and following FDA guidance as a vendor or when using a vendor METHODS Sponsors often utilize vendors for the planning and implementation of their trials. When vendors are involved in these phases with ePRO, it is not only the sponsor's responsibility, but also the vendor's to address considerations to ensure FDA expectations are met. However, meeting these expectations can be challenging across the pharmaceutical industry. To assist industry, the FDA released a Draft Guidance to communicate their perspective on how they evaluate ePRO-use for efficacy endpoints in clinical trials and for support claims made in approved product labeling. RESULTS Often, sponsors/vendors are unsure how to follow the guidance and are unaware of important considerations necessary when incorporating them in clinical trials. These considerations can include: standardizing data collection with electronic tools, handling missing values, validation, reliability, and responsiveness to clinically significant differences. EPRO-use in clinical trials requires careful planning and execution. When these considerations are not satisfied, the trials can face serious consequences by the FDA throughout the product development and approval processes. CONCLUSIONS This session intends to provide an overview of how FDA ePRO-use expectations should be met from the perspective of a vendor during the planning and implementation phases of clinical trials. Key considerations will be discussed. Fictitious examples of what could go wrong will be presented. A summary of recommendations will be provided on how to follow the FDA guidance and avoid making critical errors when employing ePROs in clinical trials