Preparing for a clinical trial feasibility assessment

A feasibility assessment helps a sponsor or CRO and a clinical research site discuss whether the study can be conducted at that location. It is a planning conversation, not a guarantee of site selection or participant enrolment. The questions and evidence requested vary by study.

Start with the protocol synopsis and the main inclusion and exclusion criteria. Note the population the study needs, the visit schedule, procedures, expected duration and any requirements that may affect who can take part. Identify questions the site needs answered before it can make a reliable estimate.

Describe the site's access to potentially relevant participants using evidence the team can explain, such as prior study experience, referral pathways or appropriately governed database information. Separate confirmed information from assumptions, account for competing studies and avoid presenting a broad population estimate as a count of available participants. A recruitment funnel from comparable studies may help explain an estimate if the data is relevant and appropriately governed.

Review staffing and operational capacity. Identify the principal investigator and relevant team roles, their experience and availability, expected coordinator workload, coverage for participant contact and any training needs. Check that facilities, equipment, pharmacy, laboratory services and accessibility arrangements match the study requirements.

List start-up dependencies, such as ethics and regulatory review, contracts, budgets, system access and staff training. Provide realistic timing assumptions and note dependencies that are outside the site's control. Requirements differ by country, institution and protocol, so confirm them with the sponsor or CRO and the site's governance team.

A useful response is specific about capability and transparent about constraints. State the evidence behind recruitment estimates, what would need to be arranged and what remains uncertain. Do not commit to enrolment numbers that the site cannot substantiate. For an example of funnel and workload reporting in Clinrol Connect, see the recruitment analytics feature page; it does not replace study-specific feasibility estimates.