The feasibility questionnaire is the first thing a sponsor learns about your site. Most sites treat it as paperwork to clear. Sponsors read it as a forecast: will this site actually enroll the patients it promises? That gap in how each side sees the same form is where good sites lose studies before the trial ever starts.
~11%
of clinical research sites enroll zero participants (Credevo)
~37%
of sites miss their own enrollment target (Credevo)
What a feasibility questionnaire actually is (and who is reading it)
A site feasibility questionnaire (SFQ, or just FQ) is the structured set of questions a sponsor or CRO sends before selecting a site. It usually arrives after a confidentiality agreement and before the pre-study site visit. On paper it asks about your investigator, your patients, your staff, and your facilities.
Underneath, it is a filter. The sponsor is deciding which sites make the shortlist and predicting how many patients each one will deliver. Recruitment already consumes up to 30% of a trial's timeline (Credevo), so sponsors screen hard at this stage to avoid a site that stalls.
Treat the questionnaire as a selection decision, not an intake form, and every answer changes. Running a structured feasibility assessment on your own site first is what makes those answers defensible. The questionnaire is a shortlisting tool. Answer it like your selection depends on it, because it does.
What sponsors are really testing in each section
Most questionnaires cover five areas. Each one asks a surface question and infers something deeper.
Investigator experience. Asks about trials run, therapeutic area, and publications. Infers whether this PI can stay compliant and keep the site clear of an FDA finding. A thin PI history reads as risk.
Patient population and access. Asks how many patients with the condition you see per year and how you would find them. Infers your realistic enrollment ceiling. This is the section that decides most selections.
Infrastructure and facilities. Asks about equipment, drug storage, and IRB. Infers whether you can run the protocol without a costly deviation on day one.
Staff capacity. Asks about coordinators, current study load, and GCP training dates. Infers whether you have bandwidth, or whether your coordinators are already maxed out across other trials.
Regulatory history and competing trials. Asks about past audit findings and other studies enrolling the same population. Infers whether a competing study at your site will pull from the same patient pool.
Every question maps to a risk the sponsor is trying to rule out. Answer the deeper question, not just the literal one.
The enrollment number that makes or breaks you
One answer carries more weight than the rest: how many patients you can enroll, and how fast. Sponsors compare that number across every site on the list, and they remember it.
Promise 20 and deliver 4, and you have not just missed a target. You have joined the 37% of sites that under-enroll (Credevo), and that number follows you into the next study's selection. Under-promise to play it safe, and a site with a bolder projection takes the slot.
The fix is not a better guess. It is a real projection built from your own data: patients per year with the condition, the share that meet eligibility, your historical screen-to-enroll rate, and the enrollment window. When your number is defensible, you can commit to it without gambling your track record.
This is also where cost lives. Patient recruitment accounts for 32% of total trial spend (Deloitte via OneStudyTeam), which is why sponsors weigh your enrollment answer so heavily.
Answer the enrollment question with data, not optimism.
The free feasibility report models your enrollment funnel and cost per randomized patient for a specific NCT number and location, so your questionnaire answer is a projection you can defend.
Get a Free Feasibility ReportHow to prepare before the questionnaire arrives
The best answers are assembled before the questionnaire shows up. Sites that scramble under a deadline submit weaker forms and miss windows. Keep a standing feasibility packet, updated quarterly.
Patient volumes by condition
How many patients you see per year for each indication you get approached for.
Diversity data
The demographic breakdown of your patient population, which sponsors now ask for directly.
Historical enrollment rates
Screen-to-enroll conversion and randomization counts from past studies, by therapeutic area.
Staff credentials
Current CVs and GCP training dates for every PI, sub-investigator, and coordinator, refreshed before they expire.
Equipment and facility list
What you have on site versus what you refer out, including storage and temperature monitoring.
Competing trials
Which active studies at your site draw from the same patient pool.
A site with a current feasibility packet answers any questionnaire in hours, with evidence, while competitors are still pulling charts. The same discipline that closes enrollment gaps is what builds the packet in the first place.
Answering competitively without over-committing
A strong answer shows your work. Instead of a bare number, walk the sponsor through the math.
"We see roughly 400 patients per year with moderate to severe [condition]. Around 30% meet the core eligibility criteria. Based on our screen-to-enroll rate on comparable studies, we project 12 randomized over a six-month window, with capacity to add a second coordinator if the sponsor needs to accelerate."
That answer does three things a bare "12" cannot. It proves you understand your own funnel. It signals honesty, which sponsors weight after years of inflated projections. And it gives you a defensible position if enrollment runs behind, because the assumptions are on record.
Never leave a question blank. A blank field reads as "we do not know," and a sponsor cannot select what it cannot assess. If a question does not apply, say so and explain why. Show the funnel, not just the finish line.
Red flags that get sites cut
Some mistakes end a site's chances before the science is even discussed.
Signing the CDA without reading it. The confidentiality agreement usually arrives first, and sites routinely breach it the moment they sign because they never read the obligations (Trafford Research). Review it, or have counsel review it.
Missing the window. CROs cap how many questionnaires they accept per study, and the qualification cycle runs about a month on average (Applied Clinical Trials). Submit late and your form may never be read.
No PI involvement. A questionnaire completed entirely by a coordinator, with no visible investigator engagement, signals a disengaged PI. Sponsors notice.
Over-promising enrollment. The inflated number that wins this study loses you the next three.
Blank or vague fields."Adequate," "sufficient," and "extensive" are not answers. Numbers are.
If you are weighing whether a study even fits your site before you invest hours in its questionnaire, check whether the study qualifies first. Most cuts happen for process failures, not clinical ones. Control the process and you stay on the list.
After you submit: follow-up and reading the signals
Submission is not the end of the site's job. Follow up promptly to confirm receipt and restate your interest. If you have heard nothing after about a month, follow up again to learn where site selection stands (Trafford Research).
Silence is not always rejection. Selection timelines stretch, and a polite check-in keeps your site visible. If you are not selected, ask why. The feedback tells you what to strengthen before the next questionnaire, and it keeps the relationship open for the study after this one.
The sites that follow up stay top of mind. The ones that go quiet get forgotten.
The questionnaire is a forecast
A feasibility questionnaire is a forecast, and sponsors keep score of whose forecasts come true. The sites that win consistently are not the ones with the boldest numbers. They are the ones whose numbers hold up, study after study, because they answer from real data instead of hope.
That discipline compounds. Every accurate projection you deliver makes the next questionnaire easier, because your track record does the arguing for you. Clinical Enroll has delivered randomization across 30+ indications at an average of $1,588 per randomized patient across six published case studies, and the pattern behind those results is the same one that wins questionnaires: enrollment answers grounded in what a site can actually do.
Phase 3, vTv Therapeutics T1D
$2,500 CPP
8 randomized across three site locations · $20,000 investment
Read the case studyPhase 1/2a, Blue Lake Biotechnology RSV
$4,285 CPP
7 randomized across three site locations · $30,000 investment
Read the case studySources: Credevo (feasibility questionnaire guidance and site enrollment statistics); Deloitte via OneStudyTeam (patient recruitment cost share); Applied Clinical Trials (site qualification process benchmarking); Trafford Research (questionnaire completion practices); Clinical Enroll (first-party CPP data from published case studies, clinicalenroll.com/case-studies).