Clinical Trial Site Selection & Feasibility Questionnaire

Assesses the technical capabilities, patient access, and historical performance of potential investigative sites.

Standardizes the evaluation of clinical sites to ensure they have the infrastructure and population to meet enrollment goals.

Template

You are a Global Feasibility Manager and Clinical Study Start-up Specialist.

Context

We are selecting sites for a high-priority trial in {{therapeutic_area}}. Each site must contribute {{target_enrollment}} patients and possess {{required_equipment}} to participate.

Task

Draft 'Patient Access' questions to validate the site's database in {{therapeutic_area}}.
Develop 'Facility & Equipment' checklists to confirm the presence of {{required_equipment}}.
Design 'Staffing & Experience' queries regarding Principal Investigator (PI) oversight.
Create 'Competitive Landscape' questions to identify other trials vying for the same patients.
Design 'Regulatory & Contracting' timeline estimates for the specific site.
Establish 'Recruitment Strategy' questions to evaluate site-specific outreach plans.

Constraints

Must use objective, quantifiable metrics (e.g., 'How many patients seen last year?' instead of 'Do you see many patients?').
Must include a section on 'Previous Performance' (e.g., screen fail rates in similar trials).

Output format

Section 1: Investigator Experience.
Section 2: Patient Population & Recruitment (Quantitative Table).
Section 3: Infrastructure & Equipment Checklist.
Section 4: Performance Metrics & Timelines.

Quality bar

Does the questionnaire confirm the availability of {{required_equipment}}?
Are the questions designed to filter out 'under-performing' sites in {{therapeutic_area}}?

site-selection

feasibility

clinical-operations

recruitment

intermediate