What Is Site Feasibility in Clinical Trials?

Feasibility is the step where a sponsor decides whether your site is right for a specific study. Think of it as an audition. Every time you want to run a trial, you go through it, so getting good at feasibility is a big part of winning studies. It has two parts: a questionnaire on paper and a qualification visit in person.

First, two different things called "feasibility"

These get searched interchangeably and they are not the same thing:

• Site feasibility — the selection process this article is about. A sponsor assesses whether your site can run their protocol. It happens once per study, per site.
• A feasibility study — an actual trial. A small preliminary study run before the main trial to find out whether a larger trial is workable at all: is the intervention deliverable, will patients tolerate the schedule, do the endpoints behave. It is a research question, not a site assessment. A pilot study is related but narrower — the main trial run in miniature. The methodology literature treats pilots as a subset of feasibility studies, not a synonym for them.

If a sponsor asks you to "complete feasibility," they mean the first one. If a protocol is described as a feasibility study, that is the study's design, and it still goes through site feasibility like any other trial.

What feasibility actually means

When a sponsor or CRO has a study to place, they don't pick sites at random. They run a feasibility assessment to work out which sites can realistically enroll the patients and run the protocol properly. It's their risk check. For you, it's the gate you pass through to get the study.

The feasibility questionnaire

For a given protocol, the sponsor sends a questionnaire. Underneath all the questions it's really asking two things: can you fill this study, and can you run it without cutting corners.

Answer honestly and specifically. Sponsors can spot inflated patient numbers, and promising big then under-enrolling is how a site earns a bad reputation. Concrete and defensible beats optimistic every time.

What a feasibility questionnaire actually contains

The form goes by several names — feasibility questionnaire, FQ, site feasibility questionnaire, pre-study questionnaire — and the wording differs by sponsor, but the sections are broadly consistent:

• Site and investigator details. Legal site name, address, the PI's name and CV, sub-investigators, and often a GCP training date. See how to become a Principal Investigator for what sponsors expect here.
• Patient population. Counts for the target condition, and an estimate of how many would meet the key inclusion and exclusion criteria. This is the section sponsors scrutinize hardest.
• Competing studies. Other trials you are running or about to start that recruit from the same pool. Under-disclosing here is a fast way to lose credibility.
• Staff and capacity. Coordinators, their experience, how many studies each carries, and who covers what on the delegation log.
• Facilities and equipment. Exam and procedure rooms, monitoring space, refrigeration and temperature logging, ECG, imaging, whatever the protocol needs.
• Laboratory. Local lab, central lab kit handling, centrifuge, sample processing and shipping, and whether you can meet the protocol's timing windows.
• Pharmacy and drug storage. Secure, temperature-controlled storage, accountability records, and who dispenses.
• Regulatory and IRB. Whether you use a central IRB or a local one, and your typical submission turnaround.
• Records. Your EMR, how you produce source documents, and your experience with electronic data capture.
• Track record. Prior studies, enrollment against target, and any audit history.

One practical note: the questionnaire usually arrives with a protocol synopsis, which is confidential. That is why a CDA is normally signed before or alongside it. If a sponsor sends you a synopsis with no confidentiality agreement in place, ask.

The site qualification visit

If the questionnaire looks good, a monitor (a CRA) comes out, or does it remotely. This is the site qualification visit, sometimes called a pre-study visit. They tour your space, check your drug storage, look at how you keep records, and talk to your team to confirm you can actually do what the questionnaire claimed. Clear this and you move on to contracts and start-up.

Where feasibility sits in the start-up sequence

Feasibility is two steps of a longer chain, and knowing the order tells you what "we're still in feasibility" actually means when a CRO says it:

1. CDA signed — so the sponsor can send you the protocol synopsis.
2. Feasibility questionnaire — the paper assessment.
3. Site qualification visit (SQV) — the in-person or remote check. Also called the pre-study visit.
4. Site selection — the sponsor decides. This is the actual yes or no.
5. Budget and clinical trial agreement — per-patient and per-visit costs, payment terms, indemnification. Often the slowest step, and the one most within your control to speed up.
6. Regulatory package and IRB approval — financial disclosures, CVs, licenses, lab certifications and normal ranges, plus Form FDA 1572 on drug and biologic studies. Device trials use an Investigator Agreement instead of a 1572.
7. Site initiation visit (SIV) — protocol training for the whole team. Different from the SQV: the SQV asks whether you can, the SIV shows you how.
8. Green light and first patient in.

Two things follow from that order. Site selection happens at step 4, so a site that clears feasibility has not yet been chosen — plenty of qualified sites get assessed and not selected, and that is not a reflection on the site. And most of the delay sites complain about lives in steps 5 and 6, which usually run in parallel and which are paperwork, not judgment. Having your regulatory documents current before a study ever appears is the cheapest speed you will ever buy.

How to pass feasibility

• Know your numbers. Real, defensible counts for the condition, not a hopeful guess.
• Don't over-promise enrollment. Under-promising and then over-delivering is what builds the track record that wins your next study.
• Have your site profile ready. A tight summary of your patients, staff, equipment, and experience makes you look prepared. The how to become a clinical trial site guide covers building one.
• Move quickly. Sponsors work on timelines, and slow responses lose studies.

Feasibility is also your filter

It runs both ways. A study that doesn't fit your patients, or that would swamp your staff, is one to turn down. Saying yes to the wrong study and failing to enroll costs you more than a polite no ever would.

The bigger picture

Feasibility only happens once a sponsor is already talking to you. Getting into that conversation is the real bottleneck, which is covered in how research sites find and win studies. Once you're in it, feasibility is where you prove you can deliver.

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This is general information, not medical, legal, or regulatory advice. Feasibility requirements vary by study and sponsor.