Clinical Trials: Feasibility Questionnaire Design

Key Questions to Include in a Feasibility Questionnaire

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Before selecting sites and investigators, sponsors and CROs must carefully evaluate a site’s ability to successfully execute a clinical trial. A feasibility questionnaire is one of the most important tools for this assessment. These documents collect structured information about a site’s resources, patient pool, regulatory experience, and infrastructure readiness. Regulatory agencies such as the FDA, EMA, and national authorities expect sponsors to document feasibility efforts as part of Good Clinical Practice (GCP) compliance. Without a robust feasibility process, sponsors risk delays, under-enrollment, and inspection findings during trial audits.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Customizing Feasibility Tools by Therapeutic Area

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While feasibility questionnaires are a standard component of clinical trial planning, a “one-size-fits-all” approach often results in incomplete or misleading data. Different therapeutic areas present unique operational, regulatory, and recruitment challenges. Therefore, it is essential to adapt feasibility tools based on the specific clinical, procedural, and patient population characteristics of each therapeutic indication.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Using Historical Site Data for Questionnaire Development

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Feasibility questionnaires are foundational tools in clinical trial planning. They help sponsors and CROs identify and select high-performing sites based on several factors like patient pool, investigator experience, infrastructure, and regulatory track record. However, when these questionnaires are designed without historical context, they can result in overly optimistic or inaccurate site responses. That’s where leveraging historical site data becomes critical.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Common Pitfalls in Feasibility Survey Design

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Feasibility surveys are the first checkpoint in clinical trial execution. Sponsors, CROs, and clinical teams rely on these tools to determine which investigator sites are capable of enrolling, complying, and delivering high-quality data. However, flawed survey design can compromise this entire process—leading to site underperformance, protocol deviations, missed enrollment targets, and costly delays. Regulatory authorities like the FDA and EMA have highlighted the importance of accurate feasibility assessments in multiple inspection reports.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Leveraging Digital Platforms for Feasibility Collection

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Traditional feasibility collection in clinical trials involved paper-based questionnaires, spreadsheets, and email threads—an approach that was time-consuming, error-prone, and lacked standardization. As clinical trials have grown in complexity and scale, especially across multinational regions, digital platforms have become essential tools for collecting, analyzing, and managing feasibility data.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Regulatory Compliance in Feasibility Assessments

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Feasibility assessments are not merely operational tools for site selection—they are regulatory expectations. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), along with other global authorities, expect sponsors and CROs to conduct structured and documented feasibility assessments as part of Good Clinical Practice (GCP) compliance. Feasibility questionnaires, data validation, and documentation must align with ICH E6(R2), which emphasizes risk-based trial planning and site qualification.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Evaluating PI Experience Through Questionnaires

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The success of any clinical trial relies significantly on the capabilities of the Principal Investigator (PI). A well-qualified PI ensures proper protocol execution, adherence to Good Clinical Practice (GCP), efficient patient recruitment, and timely data entry. As such, assessing PI experience during the feasibility process is a regulatory and operational necessity. Regulatory authorities like the FDA, EMA, and PMDA emphasize robust PI qualification checks during inspections and sponsor audits.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Global Site Feasibility: Regional Variations

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In today’s globally conducted clinical trials, one of the most critical success factors is effective site feasibility planning across diverse geographic regions. From Asia to Europe, Africa to Latin America, clinical sites operate under different regulatory frameworks, healthcare infrastructures, ethics committee procedures, and cultural norms. Applying a uniform feasibility questionnaire across all these regions without localization can lead to inaccurate data, regulatory non-compliance, and delayed trial startup.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Validation of Feasibility Questionnaire Responses

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Feasibility questionnaires play a critical role in determining whether a clinical trial site is suitable for participation. However, these tools are only as good as the accuracy of the responses they generate. Self-reported data—if unverified—can lead to unrealistic enrollment projections, infrastructure mismatches, and serious regulatory non-compliance during inspections.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection

Improving Site Selection Using AI-Based Feasibility Tools

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Clinical trial site selection has traditionally relied on manual feasibility questionnaires, investigator self-reporting, and subjective decision-making by sponsor teams. These legacy methods are often inconsistent, time-consuming, and vulnerable to bias. They fail to leverage the enormous amount of historical and real-time data now available in clinical trial systems, EHRs, and public registries.
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Feasibility Questionnaire Design, Study Feasibility and Site Selection