Feasibility Questionnaire: What Should You Know About and Include In It?

Clinical trial feasibility is a process that evaluates the possibility of conducting a clinical trial in a specific region or at selected medical centers/sites. It answers key questions: Can we finish on time? Can enough patients be recruited? Is it financially and operationally feasible? This is an integral step in initiating any clinical trial and is typically guided by a clinical trial feasibility questionnaire or a site feasibility questionnaire. These tools help researchers systematically assess site capabilities, patient availability, regulatory readiness, and other critical factors as part of the overall feasibility assessment in clinical trials, ensuring the study is well-planned and set up for success.

Feasibility Questionnaire for Clinical Trials: Template, Complete Guide & Best Practices

A feasibility questionnaire (FQ) is the set of questions prepared by a study sponsor or contract research organizations (CROs) to identify the potential and interest of a site/investigator to run clinical trial feasibility successfully.

Download Feasibility Questionnaire Format
From our experience in conducting many clinical trial feasibility and suggestions from industry experts, we have identified a list of many questions that can be helpful in designing your feasibility questionnaire. We’d love them to be used in your clinical trial feasibility.
Click here to download feasibility questionnaire format for conducting clinical trial feasibility

Why feasibility questionnaire?

A detailed clinical trial feasibility assessment is an important step towards conducting a successful clinical study. Hence, a feasibility questionnaire becomes an important tool in ensuring successful project planning.

As per one analysis,

Participant recruitment consumes up to 30% of the total clinical trial timeline, making it one of the drivers of study delays.
Around 11% of clinical research sites do not enroll a single participant throughout the trial period.
Nearly 37% of sites underperform, enrolling fewer patients than planned.

These factors increase costs, lengthen study timelines, and place additional burden on high-performing sites. However, a strong feasibility questionnaire helps identify these risks early, improve site selection, and set up the study for smoother execution.

Below are the main advantages of using a feasibility questionnaire:

The clinical trial feasibility questionnaire helps determine whether to engage with particular countries and sites by identifying their unique challenges and enabling more efficient selection.
Clinical trial feasibility questionnaires help in identifying region-specific or even institution-specific practices that can have an impact on overall study completion.
Asking questions can inform the design and implementation, avoiding major downstream and operational problems.
It’s an efficient way to collect certain types of information for screening purposes and as the basis for a discussion.
The benefits of a proper feasibility assessment become evident during trial execution.
With proper planning, unnecessary protocol amendments, delays due to recruitment challenges, and operational problems can be avoided.
From feasibility, if it is realised that a site is not fit due to a limited patient pool, insufficient resources, or a lack of expertise, Sponsors and CROs can decide not to proceed with that site and save time for all parties.
When previous site survey data are available, it allows evaluating site capability and spares the site from providing duplicate information.

How does an FQ help an investigator/site?

An FQ is not only a pragmatic approach for a sponsor, but it also helps the investigator and his/her staff to understand and accept the

Investigational nature of the study and the investigational product.
Expectations to access an appropriate subject population.
Roles and obligations as defined in the study contract and protocol.
Applicable regulatory requirements and responsibilities to the IRB/EC.
Content, maintenance, and retention of source documents, records, and Investigational products.

In order to determine the best design for your FQ, it is important to consider the type of feasibility study that you intend to perform.

Learn about clinical trial feasibility – Important tool before you conduct a clinical trial

Types of Feasibility Studies

There are primarily three types of feasibility assessments conducted at different stages of trial planning:

Early engagement
Country-level feasibility
Investigator & Site-level feasibility

Early engagement

This type of feasibility assessment begins during protocol development, before the study design is finalized. It connects sponsors with investigators, key opinion leaders (KOLs), and potential sites to gather critical insights early in the process.

This assessment is most important for trials with:

Rare or hard-to-find patients, scattered across different locations
Strict eligibility criteria that make recruitment challenging
Complex or novel study designs that need expert input
A history of recruitment or retention problems in similar studies

Key activities include:

Arranging meetings with key opinion leaders: These experts provide valuable feedback on protocol feasibility and design elements.
Running advisory boards to improve the protocol: Gather multiple stakeholders to review and refine the study design before finalization.
Finding experienced sites with good track records: Identify facilities that have completed similar trials in the past.
Learning about local practices and operations: Understand how the standard of care differs across regions and what operational challenges might exist.

Country-level Feasibility

This type of feasibility assessment evaluates which countries can best support the trial. It takes a broad view, analyzing entire countries or regions to determine where the study should be conducted.

Click here to learn about Country-Level Clinical Trial Feasibility: Top 7 Key Areas To Explore

Key evaluation criteria include:

Disease prevalence and patient landscape: Analysis of how common the condition is and how many eligible patients exist in each country.
Scientific relevance and therapeutic expertise: Availability of specialists and research experience in similar therapeutic areas.
List of suitable sites: Geographic mapping of facilities that could participate in the trial.
Assessment of facilities and resources: Evaluation of equipment, staff expertise, and technological capabilities.
Regulatory requirements and timelines: Overview of approval processes, ethics committee procedures, and expected timeframes.
Operational readiness: Analysis of logistics, supply chain capabilities, and local support systems.
Vendor support options: Availability of labs, imaging centers, and other essential service providers.
Budget projections: Cost estimates for conducting the trial in each country.

Investigator & Site-level Feasibility

After countries are selected, this type of feasibility assessment narrows focus to identify specific investigators and sites within those countries. This is the most detailed assessment, focusing on individual capabilities and readiness.

The evaluation process involves three steps:

Identify candidates based on location, specialty, and preliminary qualifications.
Distribute detailed surveys asking about experience, patient access, resources, and capacity.
Review answers to assess whether each site truly has the expertise, patients, infrastructure, and commitment needed.

Key assessment components include:

Investigator qualifications and experience: Assessment of the lead investigator’s training, publications, and experience with similar trials or conditions.
Site readiness and infrastructure: Evaluation of physical facilities, equipment, staff availability, and technological systems.
Recruitment plans and patient access: Understanding of how the site will identify, screen, and enroll patients within expected timelines.
Regulatory and operational considerations: Review of the site’s experience with ethics submissions, informed consent processes, and study management.

Key findings from questionnaires: Summary of strengths, concerns, and any challenges that emerged during evaluation.

When the sponsor or CRO is evaluating multiple potential centres (often across different regions), a web-based feasibility questionnaire becomes the tool of choice.

What is a Web-based questionnaire?

Web-based questionnaires are generally applied when the sponsor has multiple centers to conduct clinical trial feasibility. It’s also helpful in epidemiological studies and survey studies.

Web-based questionnaires with branching questions can efficiently collect the required information.
It helps the CRO/sponsor when there are multiple regions, centers, sites, and investigators.
The industry has access to many applications that can quickly set up a web-based system.

Advantages of a web-based feasibility questionnaire

Online systems offer audit trails, reporting tools, and electronic tracking with quick setup and response times.
Immediate responses from potential collaborators save significant time and resources in decision-making and trial setup.

Credevo offers a well-structured and customizable web-based system tailored to meet your specific study needs.

Depending on the type of feasibility assessment, you can then set clear objectives for your FQ to achieve.

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set of recommended questions for your FQ, or

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See details below (including a link to download a sample FQ format)

What are the FQ objectives?

In most feasibility assessments conducted at the site or investigator level, the objectives of the FQ prepared by a sponsor or CRO may include:

Determining the site/investigator’s level of interest in the study.
Assessing the readiness of the site/investigator to fulfill project expectations.
Obtaining statements and commitments.
Collecting information useful for adapting or managing the study.
Helping the site consider operational aspects, such as subject recruitment.
Determining whether the disease under study is relevant to the patient population.
Evaluating anticipated regulatory and ethical challenges, as well as general timelines for study approval and site start-up.
Evaluating the overall commitment of potential partner country offices, CROs, and sites toward completing the program.

It is also possible to add/modify/delete more points in this list and make the objectives more relevant to the project. The responsibility to set the objectives of FQ rests with the sponsor and trial manager.

Having set the objectives, the next step is to consider important points, formats, DOs, and DONTs of FQ.

Designing FQ

Format of Feasibility Questionnaire (FQ)

Format of a questionnaire generally includes sections pertaining to

Introduction,
Summary of study,
Purpose,
Contact address,
Body and
Conclusions.

Important Points

Before designing an FQ, here are some points to be considered

The language of the questionnaire should be considered based on the region and site/investigator.
The purpose of a questionnaire should be clearly described.
FQ should be necessary, sufficient, clear, and unambiguous for the purpose.
Straightforward, adequate options, and space for the answer.
Allow a broad range of answers and not reveal the “right” answer.
Accommodate the characteristics of different types of sites.
Generate answers that the sponsor can interpret, score, and validate for predictive ability.

Additionally, there are a few suggestible Do’s and Don’ts. These are as follows:

Do’s	Don’ts
A compact and easy questionnaire	A format in True/False, multiple-choice, and numeric answers, as they do not reveal the site’s thought processes
Elicit comments and allow space to elaborate	Sloppy questionnaires with typos, ambiguous questions, and inadequate space for answers
A detailed summary of the study and sponsor	Asking the same question in two different ways and having all fields marked as required
Allow skipping of questions, particularly in the electronic questionnaire	Assuming that there’s only one PI at a site
If web-based FQ, allowing sites to elaborate on the information, as it may not be easily answered by using a single number in the data entry field	Sending out a survey that can’t be printed
Giving sites the time they need to get the best possible answers	Imposing tight deadlines that rush sites into superficial or incomplete responses
Providing sponsors’ contact information	Not providing clear help channels or support guidelines, leaving sites without timely assistance.

Having considered all these factors, one is now ready to design a well-structured FQ.

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Try web-based feasibility for your clinical trial

Site Feasibility Questionnaire for Clinical Trials: What to Include and Why It Matters

Download Feasibility Questionnaire Format

Click here to download feasibility questionnaire format for conducting clinical trial feasibility