ABSTRACT
This chapter describes the development of diary and eDiary methods and discusses why they place such a high premium on patient compliance. A key objective of diary methods is to collect data closer to real time, and thus to minimize recall bias. The importance of this objective is illustrated by the fact that diaries have been used for well over half a century to collect PRO data from hundreds of thousands of patients in clinical research Patient Reported Outcome (PRO) data are common and important in clinical research. Patients are also asked to make global evaluations about their well-being and health-related quality of life (HRQoL). Though the use of PRO data in clinical research has always been standard practice, the Food and Drug Agency (FDA) has only recently released final guidance on PRO assessments and on the development and use of methods used to collect PRO data.
