Site feasibility checklist

People and protected research time

Identify the principal investigator, coordinator and support staff. Review responsibilities, study-relevant experience and available time. Assess the effect of routine clinical work and competing studies on recruitment, visits and timely documentation.

• Relevant qualifications, registration and training
• Protocol-specific delegation and supervision
• Coverage during absences
• Medical and safety escalation contacts

Patient pathways and recruitment assumptions

Estimate recruitment using the protocol's actual eligibility criteria and verified care pathways. Document the observation period and denominator behind estimates. Consider referral patterns, competing trials, visit burden and retention. Do not use general disease prevalence as a recruitment commitment.

Procedures, facilities and supplies

Walk through the study schedule at the candidate site. Identify where each procedure will happen, who performs it and how results become part of the study record.

• Laboratory methods, sample processing and transport
• Imaging, equipment and maintenance
• Product storage, temperature control and accountability
• Emergency assessment and appropriate clinical care
• Power, connectivity and backup arrangements

Consent and participant experience

Assess language, literacy, private discussion space and the time needed for consent. Review arrangements for assent or legally acceptable representatives where applicable. Consider transport, visit timing and reimbursement without assuming participants can absorb the study burden.

Institutional permissions and records

Confirm the institution's research permissions, recognized ethics remit and rules for source-record access. Understand how authorized monitors will review records and how confidentiality will be protected. Check document retention, access ownership and the continuity plan if key staff leave.

A defensible readiness decision

For each criterion, record the evidence, gap, corrective action, owner and due date. Distinguish a site that is potentially suitable from one authorized and ready to recruit. Reassess material changes in the protocol, team or resources before activation.