The Complete RWE Study Checklist

A credible RWE study starts with the right structure. This checklist helps you systematically assess your study design across seven domains covering everything from a well-defined research question to bias mitigation and outcome validation.

The checklist highlights common gaps such as poorly defined comparators, unbalanced populations, or unclear follow-up periods. It’s designed to support protocol development, steering board discussions, and internal review processes.

What’s included:

• Structured checklist covering:

  • Research question & design

  • Data source

  • Study population

  • Comparator groups

  • Observational period

  • Variables

  • Methods & bias

• Prompts to flag risks and design weaknesses early

• Supports consistency across global and local study teams

• Bonus: access to the Quick RWE Checklist, including a calculator to assess study completeness at a glance