FDA 522 Site Feasibility Calculator
Use this calculator to pressure-test whether your planned site network can realistically hit Section 522 enrollment and data-quality targets. It converts high-level assumptions into a feasibility score so teams can right-size provider scope before contracting.
Interactive Calculator
Run the calculator to see enrollment pressure, timeline estimate, and feasibility tier.
Why This Matters for 522 Programs
Section 522 programs fail less from protocol writing and more from operational mismatch. Teams often build a protocol that assumes stable enrollment, quick site start-up, and strong data discipline, then contract providers that are optimized for only one of those dimensions. A feasibility score clarifies where execution risk actually sits.
The most expensive 522 delays usually come from compounding effects: one month of activation slippage, one or two weak-enrolling sites, and slower query resolution that delays evaluable datasets. None of these issues alone looks catastrophic. Together they can shift interim and final report timing enough to force unplanned escalation and extra spend.
Running this model early helps you define realistic service-level expectations in provider negotiations. If your assumptions indicate a narrow margin, you can require stronger site activation support, tighter data cleaning cadence, or explicit back-up site activation terms in the contract.
How to Interpret the Score
High feasibility indicates your current assumptions provide workable schedule buffer. You should still track retention and query latency because both can shift quickly as enrollment scales.
Moderate feasibility means your plan can work, but likely needs controls: reserve sites, tighter governance, and defined thresholds that trigger corrective actions.
Low feasibility means the proposed network is unlikely to achieve target evaluable data without major adjustments. Before provider selection, recalibrate enrollment assumptions, expand site coverage, or increase operational support scope.
Operational Levers That Improve Feasibility
Site mix discipline
Do not treat all sites as interchangeable. Include a balanced mix of high-throughput anchors and contingency sites that can activate quickly when enrollment drifts below plan.
Retention governance
Retention assumptions should be owned explicitly. Define attrition triggers and mitigation playbooks before enrollment begins to avoid reactive protocol churn.
Data query speed
Query turnaround is a schedule lever, not just a data-quality metric. If unresolved queries accumulate, your “enrolled” cohort may not translate into evaluable evidence at reporting milestones.
Decision cadence
Run monthly feasibility refreshes with the same assumptions framework. Consistent refreshes help leadership intervene early rather than after major timeline variance.
Provider Selection Questions Based on Feasibility Risk
- How fast can the provider activate reserve sites if enrollment variance exceeds threshold?
- What query-resolution SLA can they commit to, and how is it measured?
- How do they report retention risk and corrective actions by site?
- Can they provide auditable evidence of prior 522 programs with similar operational constraints?
- What commercial terms apply if activation or enrollment assumptions change mid-program?
These questions convert generic provider claims into measurable operating commitments aligned with your feasibility profile.
References
- [1] FDA, Postmarket Surveillance Under Section 522: official overview
- [2] eCFR, 21 CFR Part 822: regulatory text
- [3] FDA CDRH, Postmarket requirements resources: postmarket requirements hub