Best practice recommendations and considerations for designing and electronically implementing event-driven diaries in clinical trials

This is the authors' abstract. We don't add key points for this paper.

Based on the literature and collective experience and consensus of the authors, this article provides a definition for an event-driven electronic diary (EDeD), outlines considerations for the use of EDeDs, and provides best practice recommendations for their design and implementation in clinical trials. This is a much-needed resource to optimize data quality in clinical trials and to support a necessary level of standardization using this form of data capture.