Published on 22/12/2025
Designing Site Feasibility Questionnaires that Drive Successful Clinical Trial Site Selection
A well-designed site feasibility questionnaire (SFQ) is essential for evaluating and selecting the right sites for clinical trials. The SFQ allows sponsors and CROs to collect critical operational, regulatory, and clinical information from potential sites to assess their suitability for a given study. This guide explains how to create effective, actionable feasibility forms that enable informed decisions during trial planning.
Purpose of a Site Feasibility Questionnaire
The site feasibility questionnaire serves as a foundational tool for:
- Evaluating a site’s ability to comply with study protocols
- Assessing site infrastructure, patient pool, and staff availability
- Identifying regulatory, logistical, or operational challenges
- Facilitating early communication between sponsor and investigator
Core Components of a Site Feasibility Questionnaire
1. Site and Investigator Information
- Site name, address, and contact information
- Principal Investigator (PI) qualifications and experience
- GCP training certificates and prior trial participation
2. Study Experience and Therapeutic Expertise
- Experience with the specific indication or similar trials
- Number of studies conducted in the last 2 years
- Regulatory inspection history and outcomes
3. Infrastructure and Equipment Availability
- Availability of pharmacy, laboratory, and diagnostic facilities
- Access to equipment required by the protocol (e.g., ECG, centrifuge)
- EDC and internet capabilities for remote data entry
4. Patient Population and Recruitment Capacity
- Estimated number of eligible patients per month
- Access to target patient
5. Operational Readiness
- Site’s SOPs for trial conduct
- Availability of dedicated study coordinators
- Turnaround time for ethics committee (EC) and regulatory submissions
Best Practices in Questionnaire Design
- Use Standardized Templates: Leverage validated templates from Pharma SOP templates or sponsor-provided forms to ensure uniformity.
- Design Study-Specific Sections: Include questions aligned with the protocol requirements such as number of blood draws, patient diary handling, or imaging capabilities.
- Include Objective and Subjective Responses: Use checkboxes, drop-downs, and rating scales, but also allow free-text for investigator comments.
- Keep It Concise: Limit the form to critical fields, ideally within 4–6 pages, to encourage completion.
- Digital Distribution: Utilize tools like REDCap, SurveyMonkey, or CTMS-integrated forms to capture responses electronically.
How to Analyze Feasibility Responses
Once responses are collected, sponsors and CROs should evaluate them against pre-defined feasibility criteria:
- Protocol-specific capabilities
- Patient recruitment projections
- Site compliance history and audit results
- Geographic diversity and regulatory ease
Sites can be scored or ranked using feasibility algorithms embedded in CTMS or Excel-based scoring sheets.
Common Pitfalls to Avoid
- Asking too many generic questions that do not impact study execution
- Failing to update the questionnaire for each study’s protocol
- Not validating the accuracy of provided information through monitoring
- Over-reliance on past performance without evaluating current capacity
Example: Sample Questions for Oncology Trial Feasibility
- How many lung cancer patients did you enroll in studies over the last 12 months?
- Do you have access to on-site PET-CT imaging?
- Is there an in-house pharmacy capable of handling cytotoxic agents?
- Do you have GCP-certified backup investigators?
- What is your average EC approval timeline?
ICH-GCP and Regulatory Considerations
As per EMA and USFDA guidance, sponsor site evaluations must be documented and auditable. Feasibility documentation is considered essential and should be retained within the Trial Master File (TMF).
Alignment with Pharma GMP and GCP guidelines ensures that the selected sites meet international standards for ethical and scientific trial conduct. Refer to resources like StabilityStudies.in for best practices in clinical documentation.
Conclusion
Effective site feasibility questionnaires are vital for strategic site selection and trial success. By tailoring the SFQ to protocol needs and analyzing responses with a structured approach, sponsors can significantly improve recruitment timelines, data quality, and regulatory compliance. A robust feasibility process lays the foundation for a successful clinical trial lifecycle.