Considerations for Implementation of Electronic Patient Reported Outcomes (ePRO) in Clinical Studies 

A Guide to the Options, Issues, Best Practices and Learning Experiences

This document has been structured for online use via an overview that is linked to more detailed information. As this is a working and evolving document, some of the links are to an in-depth discussion on the topic, while other areas may only provide high level or no additional information. It is the intention of the Working Group that eventually all areas will be equally detailed. In addition, content in the detailed areas may change over time as experience with ePRO solutions grow.

Learning has been grouped into themes according to the overview table in section 4. Each theme is divided into sub-themes and then categories. A checklist of items to consider (with accompanying notes where appropriate) is provided for each category. A full directory of the Themes, Sub-Themes and Categories can be found in the overview table as well as the Table of Contents.

Note that neither the sequence of the list nor the amount of information implies any sort of priority or level of importance. Not all of the options have associated learning experiences (but act as place holders for future learning).

The document is intended to be used:

1)    Alongside normal operations and management support

2)    As a supplement to discussions with internal teams,

3)    Together with company experiences from past and ongoing ePRO studies