How to Evaluate Clinical Trial Site Feasibility Beyond the Questionnaire

Identify the decisions the review must support

A feasibility questionnaire can collect a great deal of information without making the next decision clear. Begin by asking what the sponsor needs to establish: investigator alignment, population access, procedure suitability, startup requirements, or the contribution a site could support. The questions should help test those decisions rather than simply fill a standard profile.

Use the protocol’s defining demands to set the review priorities. A rare treatment history, an outside procedure, a time-sensitive sample, or frequent long visits may change site fit more than a broad specialty label. Share those features with the people who understand both the clinical pathway and the local work.

Bring the relevant clinical judgment into the review

The proposed investigator should help interpret the population and assessments the study requires. Discuss the available diagnosis and treatment information, the level of clinical oversight, and any specialist involvement. A practice’s interest in research matters, but it does not replace a review of whether the actual protocol fits the proposed team.

Where several therapeutic areas overlap, clarify which expertise is essential and which relationships support the pathway. WGR’s therapeutic-area pages describe the kinds of program-specific questions that can shape this discussion. Each opportunity still requires confirmation of the proposed people, procedures, and resources.

Separate accessible records from a workable recruitment plan

Ask how the relevant patient population was identified and what the count represents. Explore which criteria can be reviewed in existing records, which require more information, and how the next conversation with a patient would happen. This helps distinguish broad access from a protocol-specific pathway.

Then connect that pathway to local capacity. Records review, clinical assessment, screening appointments, laboratory work, and follow-up each need time and ownership. A useful estimate explains those assumptions. Our discussion of patient access and enrollment forecasts offers a practical way to structure the conversation.

• Clarify the population definition and information available for review.
• Identify clinical, procedure, equipment, and staffing dependencies.
• Ask how candidates would move from identification to a prepared screening visit.
• Record assumptions and conditions behind any proposed contribution.

Carry unresolved requirements into startup

Feasibility should produce a working understanding that survives site selection. If a required procedure, staff arrangement, system, or supply remains unconfirmed, identify who will resolve it and how it affects readiness. Otherwise, the startup team may inherit a capability statement without the conditions that made it reasonable.

Our feasibility and startup approach connects clinical review with those operating requirements. The purpose is to make the transition into activation coherent: the selected practice understands the study, the sponsor understands the assumptions, and unresolved items have a practical route to an answer.

For a sister-company example, review WCR's coordinated startup workstreams across contracts, regulatory preparation, training, and systems readiness.

Review feasibility when the study changes

An amended protocol, revised target, different enrollment window, or new local commitment can change the original assessment. A useful working relationship allows the team to revisit the estimate and explain what has changed. Updating the discussion is more informative than preserving a number whose assumptions no longer hold.

For a study needing rescue-site support, this review becomes especially focused on the contribution possible within the remaining period. WGR brings protocol fit, practice-based access, central recruitment, and operational preparation into that decision. The objective is a feasible plan the proposed team can describe and support.

Make the conclusion useful to the next team

End the review with a short assessment that explains the proposed fit, evidence considered, major assumptions, and outstanding questions. Include what the sponsor or site should do next and which decision depends on that information. This makes the assessment usable to a startup team that may not have joined every feasibility discussion.

When the conclusion is conditional, explain the condition plainly. A study may fit if a procedure pathway is confirmed, staffing can be arranged, or additional records support the population estimate. That clarity helps both sides decide whether to invest in the next step. It also preserves a record of the reasoning if the protocol or operating situation later changes.