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

1. Use Standardized Templates: Leverage validated templates from Pharma SOP templates or sponsor-provided forms to ensure uniformity.
2. Design Study-Specific Sections: Include questions aligned with the protocol requirements such as number of blood draws, patient diary handling, or imaging capabilities.
3. Include Objective and Subjective Responses: Use checkboxes, drop-downs, and rating scales, but also allow free-text for investigator comments.
4. Keep It Concise: Limit the form to critical fields, ideally within 4–6 pages, to encourage completion.
5. 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.

Essential Steps and Milestones in Initiating a Clinical Study

Launching a clinical trial is a complex process that involves multiple coordinated activities, regulatory interactions, and logistical milestones. In this tutorial-style article, we’ll explore the key milestones in clinical study start-up — from feasibility assessment to site initiation — that are critical for achieving timely and compliant trial activation.

1. Protocol Finalization and Study Design Approval:

Before anything else, the clinical protocol must be developed and approved. This foundational document outlines the trial objectives, methodology, eligibility criteria, treatment plans, and data analysis strategy. Once finalized, it is submitted for internal scientific and ethical review.

• Ensure alignment with ICH-GCP standards
• Conduct scientific review with the sponsor or CRO
• Obtain necessary protocol approval from senior medical teams

2. Feasibility Assessment and Site Selection:

Feasibility studies determine whether the proposed trial can be successfully conducted at the selected sites. This includes evaluating the patient population, infrastructure, investigator experience, and logistical capabilities.

1. Distribute and analyze site feasibility questionnaires
2. Engage with sites to assess recruitment potential
3. Select sites based on capability, experience, and timeline expectations

Robust feasibility reduces risks of startup delays and under-enrollment. Guidance and examples of such approaches can be found on StabilityStudies.in.

3. Budget and Clinical Trial Agreement (CTA) Negotiation:

Before any activities begin at site level, budgeting and contractual arrangements must be finalized. This includes negotiation of trial-related costs and legal protections.

• Draft and negotiate Clinical Trial Agreement with each site
• Establish payment terms, indemnification, and insurance coverage
• Ensure contracts are signed before site activation

4. Ethics and Regulatory Submissions:

Submitting the study to Institutional Review Boards (IRBs) or Ethics Committees (ECs) and regulatory bodies is a pivotal step in clinical trial start-up. These approvals are necessary before enrolling subjects.

1. Prepare IRB/EC submission packet
2. Submit Investigational New Drug (IND) application if applicable
3. Ensure compliance with USFDA or other regional regulatory guidelines

This step also includes preparing site-specific documentation and informed consent forms for approval.

5. Regulatory Document Collection and Site File Set-Up:

Each clinical trial site must maintain a Trial Master File (TMF) or Investigator Site File (ISF) containing regulatory documents. These are collected and reviewed before the site can be activated.

• Signed protocol, CVs, medical licenses, and training certificates
• EC/IRB approval letters and subject materials
• Delegation logs, lab certifications, and study-specific SOPs

GMP principles should be followed for document control and archival, aligning with GMP documentation best practices.

6. Site Initiation Visit (SIV):

The SIV is conducted to train site personnel on the protocol, procedures, safety reporting, and data entry systems. It is a formal requirement before the site begins subject enrollment.

1. Schedule the SIV with the site’s principal investigator and staff
2. Review study objectives, timelines, safety protocols, and CRF/eCRF systems
3. Document training in site logs and confirm readiness for activation

7. Study Activation and Enrollment Start:

Once the SIV is complete and all documentation is in place, a site can be activated for subject enrollment. Study startup is deemed complete at this point.

• Activate the site in CTMS and issue site activation letter
• Start subject screening and informed consent process
• Monitor initial enrollment progress and address site queries promptly

8. Typical Start-Up Timelines and Bottlenecks:

On average, clinical study start-up timelines range from 90–150 days depending on the complexity of the trial and country-specific regulatory environments. Bottlenecks may include:

• Delayed ethics approval
• Slow CTA negotiation
• Feasibility feedback delays
• Incomplete site documentation

Risk-based planning and early engagement of stakeholders are essential strategies to reduce startup cycle time.

9. Best Practices to Streamline Study Start-Up:

To ensure a smooth and compliant start-up process, follow these best practices:

1. Use a centralized start-up tracker to manage timelines
2. Conduct pre-submission readiness reviews
3. Implement SOPs for each start-up step (refer to Pharma SOPs)
4. Preload IRB/EC forms and country-specific submission templates
5. Communicate regularly with sites and CRO teams

10. The Role of Technology in Start-Up Management:

Modern clinical operations teams utilize digital tools to manage the complexity of start-up. These may include:

• Study start-up management platforms
• Electronic TMF (eTMF) systems
• Contract management platforms for faster CTA workflows
• Automated alert systems for milestone tracking

Integration with regulatory intelligence tools also helps anticipate region-specific hurdles and ensure compliance.

Conclusion:

Effective clinical study start-up is a critical determinant of trial success. By systematically managing milestones — from protocol approval through site initiation — clinical teams can mitigate delays, ensure compliance, and accelerate patient enrollment. Adopting best practices, leveraging digital tools, and following structured SOPs contribute to robust and predictable start-up outcomes.