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An enthusiastic recruitment estimate is only one input to site selection. A practical feasibility review tests whether the protocol can be delivered with available patients, staff, facilities and competing commitments.
Question recruitment assumptions
Ask how the estimated patient pool was derived and when the underlying information was collected. Distinguish diagnosed patients from those likely to meet eligibility criteria and attend demanding visits. Record assumptions without collecting unnecessary identifiable patient information.
Walk the sample pathway
For a study requiring an early-morning timed sample, examine clinic access, laboratory processing, courier availability and staff cover. A site may have suitable patients yet lack a workable sample route. Capture the gap as a condition to resolve before activation.
Site capability checks
- Assess investigator availability and coordinator backup.
- Check competing studies and realistic screening assumptions.
- Verify protocol-specific pharmacy, laboratory and equipment capacity.
Record a conditional recommendation
Accept a site recommendation with documented evidence, unresolved conditions and a reasoned recruitment range. Revisit assumptions when the protocol or local capacity changes. Preserve the distinction between a feasibility response and a confirmed operational commitment in planning discussions. Compare estimated capacity with investigator time actually reserved; changing clinical workload can invalidate an earlier feasibility response, so record local confirmation and its date.
Frequently asked questions
- Does a large patient population ensure recruitment?
- No. Eligibility, competing studies, visit burden and site resources influence the achievable rate.
- Must every capability be present immediately?
- Identify resolvable gaps, their owners and evidence required before relevant activities begin.