Feasibility questionnaires are essential tools in the site selection process. A well-designed questionnaire gathers key data from potential trial sites, helping sponsors and CROs assess their capability to meet study requirements. However, if poorly designed, they can yield incomplete or misleading insights. In this tutorial, we explore best practices for designing feasibility questionnaires that are comprehensive, protocol-aligned, and effective in identifying high-performing sites.

Why Feasibility Questionnaires Are Important:

These questionnaires help evaluate whether a site can successfully conduct a clinical trial. They provide insight into:

• Investigator qualifications and past performance
• Access to the target patient population
• Facility, equipment, and staff readiness
• Competing studies and enrollment bandwidth
• Regulatory and ethical review timelines

Effective feasibility tools reduce delays, prevent poor site selection, and align start-up planning with realistic timelines.

Start with Clear Objectives:

Before drafting the questionnaire, define your goals:

• What protocol elements are most critical?
• Which operational challenges do you want to pre-screen for?
• Are you gathering data for site qualification, or just preliminary interest?

Tailor your questions based on study phase, therapeutic area, and trial complexity.

Key Sections to Include in a Feasibility Questionnaire:

1. Investigator and Site Details:

• Principal Investigator (PI) name, credentials, and CV
• Number of years in clinical research and therapeutic area expertise
• GCP training certificate validity
• Site location, infrastructure, and certifications

2. Patient Population Access:

• Estimated number of eligible patients in the past 12 months
• Access to hospital/clinic databases for patient screening
• Inclusion/exclusion feasibility based on protocol synopsis
• Expected recruitment timeline and dropout rate

This section helps validate enrollment projections and set realistic timelines.

3. Competing Trials and Study Load:

• Ongoing studies in the same therapeutic area
• Number of studies with overlapping populations
• PI and CRC workload management

Overloaded sites may lead to poor recruitment and protocol deviations.

4. Infrastructure and Equipment:

• Availability of temperature-controlled drug storage
• Access to laboratory services and shipping experience
• Backup systems for electricity, refrigeration, and internet

Use this to evaluate alignment with GMP-compliant operations.

5. Regulatory and Ethics Review Capabilities:

• IRB/IEC name, contact details, and approval frequency
• Timeframes for new protocol approvals and amendments
• Experience with prior study submissions

This helps anticipate delays due to ethics timelines.

6. Site Start-Up Readiness:

• Availability of SOPs and regulatory document templates
• Timelines for document completion and signature authority
• Past performance metrics for site activation

Design Tips for Effective Questionnaires:

1. Keep It Protocol-Specific: Avoid generic templates—tailor questions to each trial’s eligibility criteria and endpoints.
2. Use Logical Grouping: Organize sections by theme—investigator, patients, logistics, etc.
3. Balance Open and Closed Questions: Use dropdowns, yes/no, and numeric fields for comparability; include comments for context.
4. Include Definitions: Clarify terms like “eligible patient,” “CRC,” or “screen failure rate” to avoid misinterpretation.
5. Enable Digital Submission: Use electronic tools with auto-validation to reduce manual errors.

Digital platforms like Medidata Feasibility, Veeva, or custom REDCap forms can help standardize submissions across sites.

Common Mistakes to Avoid:

• Asking overly complex or ambiguous questions
• Failing to account for regional regulatory and logistical nuances
• Not allowing sites to explain answers or give context
• Sending the same form to both naïve and experienced sites

Designing an adaptive or branching form can help tailor depth based on responses.

Data Collection and Scoring:

Once data is collected, establish scoring models to rank sites based on feasibility criteria:

• Enrollment feasibility (30%)
• Infrastructure and staff availability (25%)
• Regulatory readiness (20%)
• Competing studies (15%)
• Investigator engagement (10%)

Use weighted scores to prioritize follow-ups and site qualification visits (SQVs).

Integration with Site Selection SOPs:

Your feasibility process should align with documented SOPs, including:

• Site selection criteria and justification
• Data storage policies and version control
• Compliance with sponsor requirements and Pharma SOP templates

Conclusion:

A well-constructed feasibility questionnaire is foundational to selecting high-performing sites and ensuring successful study execution. By following these best practices—tailoring questions to the protocol, structuring logically, enabling digital submissions, and aligning with regulatory expectations—sponsors and CROs can make informed site selection decisions with speed and confidence. For templates and feasibility scoring tools, refer to resources available at Stability Studies.