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Cover of Developing Protocols Handbook Chapter

The “Developing Protocols (Trials): Handbook Chapter” is an excerpt of the PROTEUS-Trials Handbook that describes the SPIRIT-PRO guidance for addressing the minimum elements related to PROs that should be included in clinical trial protocols.

View the entire Handbook here (US version) or here (UK version).

Citation Information
When referencing information included in the PROTEUS-Trials Handbook, we recommend citing the primary sources rather than the Handbook.

To reference the Handbook itself, please use:

The PROTEUS-Trials Consortium (Patient-Reported Outcomes Tools: Engaging Users & Stakeholders). PROTEUS Handbook. Prepared by The University of Sydney Quality of Life Office for the PROTEUS-Trials Consortium. Available at

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