Participation burden can drive risks to the efficiency of a trial such as high drop-out rates, screen failures and protocol amendments. Identifying such risks during protocol design can help to avoid costly delays and enhance participation experience.

This self-assessment tool guides sponsors or patient organizations through a structured approach for rapid risk-assessment of participation burden for a specific clinical trial design. Risk mitigation strategies are provided for consideration.

Developed and validated by experts and easy to use whether patient-centricity is new or well established within your team.

Updated 27APR2021

Questions about how to use this tool? Contact the Center for Rare Disease.

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Patient-Centric Protocol Risk Assessment Tool

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