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.

In clinical trial operations, “site feasibility” and “site selection” are often used interchangeably, yet they serve distinct purposes. Both processes are crucial during the study start-up phase, impacting timelines, recruitment, and regulatory compliance. This guide provides a step-by-step explanation of how site feasibility differs from site selection and how they interconnect in building an optimal trial site network.

What Is Site Feasibility?

Site feasibility is the preliminary assessment of a site’s capability and willingness to conduct a specific clinical trial. It focuses on technical, operational, and regulatory capacity as well as historical performance data.

• Does the site have access to the required patient population?
• Is the site equipped with the right infrastructure and equipment?
• Do investigators have therapeutic experience relevant to the protocol?

Feasibility helps sponsors and CROs narrow down which sites are theoretically capable of performing the study based on protocol requirements.

Key Activities in Site Feasibility:

1. Dissemination of feasibility questionnaires
2. Site responses including investigator CVs, enrollment projections, and staff qualifications
3. Telephonic or in-person feasibility visits (Pre-Study Visits)
4. Historical enrollment performance checks
5. Assessment of lab certifications and equipment readiness

These steps provide quantitative and qualitative inputs for ranking sites during the selection phase.

What Is Site Selection?

Site selection is the final decision-making step to choose which sites will participate in the clinical trial, based on feasibility results and strategic criteria.

• Includes evaluation of operational capability and prior GCP compliance
• Considers site responsiveness, contract negotiation history, and regulatory familiarity
• Often requires multi-level approvals (e.g., sponsor, CRO, medical monitor)

While feasibility identifies possible sites, site selection finalizes the list of actual study partners.

How Site Feasibility and Site Selection Interact:

Although feasibility precedes selection, the two are intertwined. A well-designed feasibility process leads to faster and more confident site selection. Here’s how:

• Feasibility outcomes shape selection criteria (e.g., timeline commitments)
• Negative feasibility indicators prompt exclusion or further clarification
• Feasibility feedback reveals site-specific risks during selection deliberation

Using platforms like Stability Studies can aid in standardizing feasibility assessments across global trials.

Common Tools Used:

To manage these activities, trial sponsors and CROs typically use:

• Feasibility questionnaires and surveys (paper or e-platforms)
• Site Information Forms (SIFs)
• Feasibility analytics dashboards
• Site scorecards and historical performance databases
• Contract tracking logs to evaluate responsiveness during past studies

Key Metrics for Feasibility and Selection:

Evaluating feasibility and selection is data-driven. Some key metrics include:

• Past enrollment success vs. target
• Protocol deviation history
• Site initiation timelines
• Audit or inspection outcomes
• PI workload and competing trials

These data points allow clinical teams to apply a scoring model for objective selection.

Common Challenges and How to Address Them:

1. Incomplete or inconsistent responses: Use structured digital forms and provide clear guidance.
2. Over-committed sites: Assess competing study load and site staff availability.
3. Bias in selection: Use blinded scoring systems for final ranking.
4. Non-responsive sites: Have a follow-up protocol and backup site list.

Following SOPs for feasibility and site selection ensures uniformity and regulatory readiness.

GCP and Regulatory Considerations:

According to ICH GCP (E6 R2), sponsors must:

• Ensure that investigators and sites are qualified by training, experience, and resources
• Document site qualification and justification for selection
• Maintain clear records in the Trial Master File (TMF)

Regulatory bodies such as the EMA may audit site selection rationale during inspections.

Best Practices for Harmonizing Feasibility and Selection:

• Use unified templates for feasibility across countries and CROs
• Maintain a historical site database with key performance indicators (KPIs)
• Schedule early engagement calls with sites to build rapport
• Pre-identify backup sites in case primary ones fail selection
• Integrate feasibility scoring into selection presentations for leadership buy-in

Conclusion:

Site feasibility and site selection are complementary processes that determine the quality and efficiency of clinical trial execution. By using structured tools, clear metrics, and collaborative engagement, clinical teams can ensure that selected sites meet both operational and regulatory expectations. Aligning these activities with GMP audit practices and using standardized SOPs supports transparency and long-term success.