Key Resources

Rationale

Currently, the complexity and length of current Statistical Analysis Plans (SAPs) leads to delay in review and difficulty using the resulting data. Development of a Common SAP Template would limit rework and reduce complexity.

In 2019, this initiative will develop a Common SAP Template, which aims to provide a common layout and model content for SAP documentation, and will link directly to TransCelerate’s Common Protocol Template (CPT).

Benefits

  • Alignment with the CPT and content reuse could further increase the speed at which SAPs are completed, and potentially reduce data entry errors.
  • Regulators would have greater ease of review because content would be more likely to be in a familiar location.

Available Assets

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