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Handbook Chapter

Developing Protocols (Trials): 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…

Article

“Give Us the Tools!” – Development of Knowledge Transfer Tools to Support the Involvement of Patient Partners in the Development of Clinical Trial Protocols with PROs, in Accordance with SPIRIT-PRO

This article, in support of “Developing Protocols (Trials),” adapts the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-Patient-Reported Outcome (PRO) Extension guidance to a user-friendly format for patient partners. Citation Information Cruz Rivera S, Stephens R, Mercieca-Bebber R, Retzer A,…

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