Look for operational fragility
Complex eligibility, specialist procedures, long visits, difficult logistics and unclear endpoint workflows can fail when real sites try to execute them.
Ask sites before finalizing
Protocol-specific feasibility can reveal contradictions between the design and normal clinical workflow.
Predefine what can change
Separate true scientific requirements from operational choices that can be simplified without damaging the answer.
Questions people actually ask
FAQ
Are protocol amendments always bad?
No. Some are necessary and improve a study. The goal is to avoid preventable amendments caused by untested operational assumptions.
What is the cost of an amendment?
It varies widely because the effect can include regulatory submissions, contracts, training, database changes, supplies and enrollment delay.
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