Evaluating a research site: a sponsor conversation checklist

Verify the investigator and team

Request current CVs, relevant experience, training and availability. FDA guidance addresses investigator qualifications and site adequacy. A profile alone cannot establish fit for a particular protocol.

Discuss supervision and safety

Clarify delegated responsibilities, investigator oversight and participant safety arrangements. FDA guidance emphasizes supervision, participant protection and data integrity. Ask for the evidence applicable to your study.

Turn capabilities into a documented plan

Our suggested discussion agenda includes equipment suitability, specimen logistics, staffing, language needs, recruitment assumptions and timelines. Agree a secure channel for documents. Do not interpret a website capability as an awarded study, enrollment guarantee or regulatory certification.

Sources and further reading

• FDA: Investigator Qualifications and Research Sites
• FDA: Investigator Responsibilities