feasibility survey questions – Clinical Research Made Simple

Feasibility Questionnaire Design Best Practices for Clinical Trials

digi — Sat, 14 Jun 2025 08:05:29 +0000

Best Practices for Designing Clinical Trial Feasibility Questionnaires

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:

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

How to Design Effective Site Feasibility Questionnaires for Clinical Trials

digi — Tue, 10 Jun 2025 22:56:00 +0000

How to Design Effective Site Feasibility Questionnaires for Clinical Trials

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 population through internal or referral networks
Recruitment strategies used in past studies

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.

How to Design Effective Site Feasibility Questionnaires for Clinical Trials

digi — Tue, 10 Jun 2025 12:12:00 +0000

Designing Site Feasibility Questionnaires that Drive Successful Clinical Trial Site Selection

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 population through internal or referral networks
Recruitment strategies used in past studies

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).