Which statement ensures site-level enrollment targets are documented for multisite trials?

Which statement ensures site-level enrollment targets are documented for multisite trials?

• A. The total enrollment target
• B. The per-site enrollment targets
• C. The interim analysis plan
• D. The numbers of enrolled subjects projected for each trial site

Answer: (D)

In multisite trials, you must have a clear, site-by-site plan for how many participants are expected to enroll at each location. This allows ongoing monitoring of accrual, ensures resources and timelines are realistic, and helps quickly spot sites that may be under-enrolling. The best choice directly documents the numbers projected for each trial site. When you specify the planned enrollments by site, you have a concrete, actionable plan you can compare against actual enrollments, identify gaps, and implement targeted actions to keep the study on track. This site-level documentation is essential for feasibility, risk management, and regulator/sponsor oversight. A single total enrollment target doesn’t reveal how enrollment will be distributed across sites. Stating per-site enrollment targets is close but the precise site-by-site projections give a clearer, trackable plan. An interim analysis plan relates to data analysis, not enrollment targets.

In multisite trials, you must have a clear, site-by-site plan for how many participants are expected to enroll at each location. This allows ongoing monitoring of accrual, ensures resources and timelines are realistic, and helps quickly spot sites that may be under-enrolling.

The best choice directly documents the numbers projected for each trial site. When you specify the planned enrollments by site, you have a concrete, actionable plan you can compare against actual enrollments, identify gaps, and implement targeted actions to keep the study on track. This site-level documentation is essential for feasibility, risk management, and regulator/sponsor oversight.

A single total enrollment target doesn’t reveal how enrollment will be distributed across sites. Stating per-site enrollment targets is close but the precise site-by-site projections give a clearer, trackable plan. An interim analysis plan relates to data analysis, not enrollment targets.