The Clinical Trial Site Feasibility Questionnaire: What It Asks and How to Prepare

The feasibility questionnaire is the single document that decides whether your site stays in the running for a study. Sponsors send it to more sites than they will select, they read the answers side by side, and slow or vague responses quietly end the conversation. This guide walks through what the questionnaire actually asks, what the sponsor is really checking with each section, and what to have ready before one ever arrives — because the sites that answer well in a day are the ones that prepared before the email came.

If you want the bigger picture first — where the questionnaire sits between the CDA, the qualification visit, and site selection — start with what site feasibility is and come back.

What a feasibility questionnaire asks, section by section

The form goes by several names — FQ, site feasibility questionnaire, pre-study questionnaire — and the wording varies by sponsor, but the sections are broadly consistent. For each one, it helps to know what the reader on the sponsor side is actually checking.

• Site and investigator details. Legal site name, address, the PI's CV and license, sub-investigators, GCP training dates. What they're checking: is there a qualified investigator whose paperwork won't hold up start-up.
• Patient population. How many patients you see with the target condition, and how many would plausibly meet the key inclusion and exclusion criteria. What they're checking: whether you can enroll. This is the section they scrutinize hardest, and the one where over-promising does the most damage.
• Competing studies. Trials you're running or about to start that recruit from the same pool. What they're checking: whether your eligible patients are already spoken for. Under-disclosing here reads as either disorganized or dishonest, and both lose the study.
• Staff and capacity. Coordinators, their experience, current study load, who covers what. What they're checking: whether a real person has hours for their protocol.
• Facilities, equipment, and lab. Exam rooms, monitoring space, refrigeration with temperature logging, ECG, local lab and sample processing, whether you can hit the protocol's timing windows. What they're checking: protocol-specific logistics — this list changes with every study.
• Pharmacy and drug storage. Secure, temperature-controlled storage and accountability records. What they're checking: whether investigational product is safe at your site.
• Regulatory and records. Central or local IRB, typical submission turnaround, your EMR, how you produce source documents, EDC experience. What they're checking: start-up speed and audit readiness.
• Track record. Prior studies, enrollment against target, audit history. What they're checking: whether your past answers matched your past performance.

The prep checklist: have these eight things ready before any questionnaire arrives

Most of a feasibility questionnaire doesn't depend on the protocol. A site that maintains these can answer the generic two-thirds of any FQ in an hour and spend its time on the protocol-specific parts:

1. Current PI and sub-investigator CVs, signed and dated (no regulation sets a refresh interval, but many sponsors expect one under two years old), plus medical licenses
2. GCP training certificates with expiration dates for everyone on the delegation log
3. Patient population counts by condition — real numbers, refreshed on a schedule, not a hopeful guess (more on this below)
4. A current list of active and pending studies, with which patient pools they draw from
5. Staff roster with roles, research experience, and current study load
6. A facilities and equipment summary — rooms, refrigeration and monitoring, ECG, lab capabilities, drug storage
7. IRB details and your typical submission-to-approval turnaround
8. A one-page site profile that pulls all of this together, so the sponsor sees a prepared site before they've read a single answer

That last item is the difference between a site that assembles its answers from scratch every time and one that maintains them. It's also, not coincidentally, most of what a sponsor-ready site profile contains — the guide to becoming a clinical trial site covers building one.

A feasibility response template you can copy

Searchers often want a downloadable questionnaire template. The honest advice: you'll never pick the questionnaire's format — the sponsor's form arrives as their PDF or portal, and you fill in what they ask. What a site can templatize is the response file it answers from. Keep a document with these headings filled in and current, and any sponsor's questionnaire becomes a copy-paste exercise:

[Site name] — Feasibility Response Master · Last reviewed: [date] · Owner: [coordinator name]

1. Site & investigator — legal entity name and address; PI name, specialty, license number, CV date; sub-investigators; GCP training dates
2. Patient population — counts by condition with the date of the last EMR refresh, and the query logic used (diagnosis codes, age range)
3. Active & pending studies — study, phase, sponsor, which patient pool it draws from, enrollment status
4. Staff — names, roles, research experience in years, current study load per coordinator
5. Facilities & equipment — rooms, monitoring space, refrigeration and temperature logging, ECG, imaging access
6. Laboratory — local lab capabilities, central-lab kit handling, processing and shipping, timing windows you can meet
7. Pharmacy & drug storage — storage type, temperature range, accountability process, who dispenses
8. Regulatory — IRB (central or local), typical submission-to-approval turnaround, EDC systems used
9. Track record — studies completed, enrollment vs. target, audit and inspection history
10. Standard attachments — CV, medical license, GCP certificates, lab certifications, W-9, site photos

Review it quarterly, and every questionnaire answer starts from a document that's already true.

Where patient numbers should come from

The patient-population section deserves its own discipline, because it's the one sponsors test against your later enrollment. Defensible counts come from your EMR: query by diagnosis code for the target condition, then apply the protocol's biggest knockout criteria — age range, key comorbidities, key concomitant medications — to get from "patients with the condition" to "patients who might actually qualify." Keep the counts aggregate; a feasibility answer never needs identifiable patient information.

Two honest rules keep this section safe. Report the number your data supports, not the number you think the sponsor wants — under-promising and over-delivering is what builds the track record that wins the next study. And note when you last refreshed the count; a sponsor trusts "412 patients with T2D as of last quarter" more than a suspiciously round 500.

Speed matters more than sites expect

Sponsors work down a list, and feasibility runs on their timeline, not yours. A questionnaire answered in a day says your site runs an organized operation; one answered in three weeks says the opposite, whatever the answers contain. If you can't hit a stated deadline, say so early and give a date — silence is the only unrecoverable answer. And remember the questionnaire usually arrives under a confidentiality agreement with a protocol synopsis attached; the CDA is quick to turn around if legal review is arranged in advance, and it's the first speed test you face.

Frequently asked questions

Should we say yes to a study that's a marginal fit? No. Feasibility runs both ways: a study your patients don't support becomes an under-enrollment on your permanent record. Sponsors respect a fast, well-reasoned "not this one" — it makes your next "yes" credible.

What if we have no research track record yet? Answer the experience sections honestly and let the rest of the questionnaire do the work: strong patient numbers, a trained team, and clean logistics win first studies. Everyone's first study is their first study, and sponsors do select new sites — especially where enrollment is hard.

Who should fill the questionnaire out? The coordinator usually drafts it, but the PI must review the clinical sections — eligibility judgment calls belong to the investigator — and someone should own final consistency, because a questionnaire that contradicts itself between sections is a red flag sponsors notice.

Can we decline some questions? You can ask why something is needed, and financial or proprietary details are reasonable to hold for the budget stage. But blanks read as evasions; a short honest answer beats an empty field.

Is the questionnaire the decision? It's the gate to it. Clear it and the next steps are the qualification visit and then site selection — the full sequence is laid out in the site feasibility guide.

Want your patient counts, site profile, and study pipeline ready before the next questionnaire lands? Start a free TrialWave trial, no card required — feasibility prep is most of what it does.

---

This is general information, not medical, legal, or regulatory advice. Questionnaire contents vary by sponsor, study, and protocol.