Site feasibility in clinical trials: how the assessment works and how to answer it

What is site feasibility in clinical trials?

A 2024 task force of sites, site networks, sponsors and CROs describes three stages of feasibility: program feasibility (disease prevalence, competition and geography for a development program), study or protocol feasibility (whether one protocol can meet its timelines, targets and costs), and site feasibility. Site feasibility means identifying and assessing potential sites for a specific study. It may also be called a feasibility assessment, site qualification or site selection.^⁠[1]

The regulatory basis is the sponsor's duty to choose qualified investigators. For drug studies under an IND, 21 CFR 312.53(a) says a sponsor "shall select only investigators qualified by training and experience."^⁠[7] ICH E6(R3), which FDA published as final guidance in September 2025, says an investigator should be able to demonstrate "(e.g., based on retrospective or currently available data)" a potential for recruiting the agreed number of eligible participants.^⁠[5],[6] In other words, the patient number should rest on data.

How is a site feasibility assessment conducted?

ASCO describes the typical process as "a comprehensive and lengthy site feasibility questionnaire and an in-person prestudy site visit prior to selecting the site."^⁠[2] The University of Rochester Medical Center's April 2026 start-up manual lays out the usual sequence.^⁠[4]

1. 1

   Candidate sites identified

   In a 2021 interview study, sponsors mostly used databases on previous trial performance to identify countries and sites.^⁠[10] The site hears of the study when asked whether the investigator is interested.

2. 2

   Confidential disclosure agreement (CDA)

   The site signs a CDA before the sponsor shares proprietary information. Once it is fully executed, the sponsor sends the protocol synopsis or the protocol.^⁠[4]

3. 3

   Protocol or synopsis review

   The PI and coordinator review the criteria, schedule of activities and procedures. The task force warns that a synopsis is "only valuable to determine initial site interest, not accurate site feasibility."^⁠[1]

4. 4

   Feasibility questionnaire

   The site completes the sponsor's survey, sent as an attachment or online form.^⁠[4] In an ASCO task force survey of 113 oncology practices, each questionnaire took 4 hours on average.^⁠[3]

5. 5

   Site qualification visit

   A virtual or onsite pre-selection visit, also called a site qualification visit, reviews the answers and clarifies open items. The sponsor or CRO then writes a report on the site's feasibility.^⁠[4] These visits took 10 hours on average in the ASCO survey.^⁠[3]

6. 6

   Selection and start-up

   A selected site receives a selection letter and moves into budget, contract and IRB work.^⁠[4] For IND studies, the sponsor must collect a signed Form FDA 1572 and the investigator's CV before the investigator begins.^⁠[7]

Formats vary. ASCO recommended a short questionnaire plus a pre-study visit, a long questionnaire alone, or a visit or teleconference alone.^⁠[2] The task force also saw feasibility start before protocols were final, and CROs start it before winning the study, so ask where the study stands.^⁠[1]

What should the site's own feasibility review cover?

Run an internal go/no-go in parallel. URMC's research office weighs the study pipeline, staffing, enrollment under that PI, competing studies in the same disease and past timelines with the sponsor, uses cohort discovery tools in its risk assessment, and can add a break-even analysis of the budget.^⁠[4] The task force's advice to sites is direct: decline if you are not interested.^⁠[1]

What criteria do sponsors assess in site feasibility?

The task force groups them into four areas: site profile, site capability, site performance, and protocol-specific assessment such as patient population estimates, referral patterns and standard of care.^⁠[1] CTTI's ideal site profile covers investigator experience, site capabilities, infrastructure, institutional resources and access to the target population.^⁠[9]

What do sponsors and CROs look for in a feasibility response?

Mostly, a number they can believe. ASCO recommended keeping questions to what sponsors need to know: site capability and the feasibility of the specific protocol.^⁠[2] In the 2021 interview study, sponsors validated investigators' estimates against other data and seemed to favor sites that backed patient counts with EHR data, because they answered faster and more reliably.^⁠[10] Track record counts too: a site that has run 6 to 10 trials is more likely to enroll on time than one with fewer, according to a 2018 review.^⁠[12] See how sponsors choose sites and how to win more studies.

How should a site estimate eligible patient numbers?

From the records, not from memory. "Lasagna's Law" is the observation that investigators overestimate the number of patients available for a study.^⁠[11] A 2018 review calls it a repeated pattern that study centers report fewer eligible patients than anticipated.^⁠[12] In the 2021 Nordic interview study, most sites were seen to base counts solely on previous experience, and sites that reviewed EHR data were considered more accurate.^⁠[10] Memory recalls the diagnosis, not the lab threshold or washout window that removes most candidates.

1. 1Get the full criteria. Sites cannot project enrollment accurately without all the inclusion and exclusion criteria.^⁠[1] If you have only a synopsis, say so.
2. 2Sort the criteria by where the answer lives: structured fields, notes and reports, or nowhere in the chart.
3. 3Run the count as a funnel, reporting the number left after each criterion, with the query date and lookback window.
4. 4Check a sample of charts from the bottom of the funnel and record how many hold up.
5. 5Estimate new patients per month from a stated recent period.
6. 6Convert to an enrollment estimate last, using your own pre-screen, consent and screen failure rates, and show the arithmetic.

The chart review behind a count is often done as a review preparatory to research under 45 CFR 164.512(i)(1)(ii), which requires the covered entity to obtain the researcher's representations that the review is solely to prepare a protocol or similar, that no protected health information will leave the covered entity, and that the information is necessary.^⁠[8] Send sponsors aggregate counts only and follow your privacy office's process. This is not legal advice.

Why is the eligible count not the enrollment number?

Eligible patients still have to be reached, interested, consented and confirmed at screening. A 2019 meta-analysis of 13 studies covering 8,883 cancer patients found a trial was unavailable at the patient's institution 55.6% of the time; 21.5% of patients were ineligible for an available trial, 14.8% did not enroll, and 8.1% enrolled.^⁠[13] Among patients with an available trial who were eligible, more did not enroll than enrolled. Use the stage-by-stage rates in your own pre-screening and screening logs, and if you have none, say so and give a range.

What metrics show whether feasibility was accurate?

The core test is enrolled against promised, and the industry record is poor.

The Tufts figures cover more than 150 studies and nearly 16,000 sites.^⁠[14] In the phase III AleCardio trial, the median center target was 10.1 patients and the median enrolled was 4.0. The same analysis found that 59 candidate predictors, mostly feasibility questionnaire answers, predicted which centers would meet target only marginally better than a model with no predictors.^⁠[15] A questionnaire is only as predictive as the data behind it.

What should a site feasibility checklist include?

Use this for each feasibility request. It follows the steps above, the materials the task force says sponsors should provide, and URMC's questions for sponsors.^⁠[1],[4]

• PI wants to proceed; CDA routed through your contracts office.
• Full protocol or detailed synopsis received, with all eligibility criteria and the schedule of activities.
• Lab, pharmacy and imaging manuals (draft or final) and the equipment list requested.
• Site enrollment target, overall target, enrollment period and current enrollment confirmed with the sponsor.
• Records query run against the criteria, with query date, lookback window and a count at each step.
• Chart-reviewed sample completed and the hold-up rate recorded.
• New eligible patients per month estimated.
• Enrollment estimate calculated from your own consent and screen failure rates.
• Competing studies listed and referral priority set.
• Staff time and equipment checked, including satellite locations.
• Start-up timeline stated: review committees, IRB, budget and contract.
• Internal go/no-go decided, including whether the budget covers the work.
• PI sign-off on the count, method and projection; dated copy saved.

What are the most common site feasibility mistakes?

• Answering from memory. Investigators tend to overestimate available patients, and sponsors find EHR-backed counts more reliable.^⁠[11],[10]
• Committing the eligible pool. Patients who might qualify are not patients who will be randomized.
• Answering from a synopsis without saying so. In the task force's examples, sites learned at initiation that a study needed a refrigerated centrifuge, an on-site lab test their satellites could not run, or a hazardous compound hood. One site withdrew after finishing all start-up work.^⁠[1]
• Ignoring competing studies that split the pool you counted.
• Contacting patients to test interest. That is recruitment, not feasibility. ICH E6(R3) lists recruitment advertisements and the recruitment process among what an IRB reviews.^⁠[5] See IRB and HIPAA rules for patient outreach.
• Never checking the answer against actual enrollment, so the next estimate repeats the last one's errors.

How does Bond help sites answer feasibility with data?

Bond Health gives a site the data behind its feasibility answers and then delivers the enrollment; the site still completes the questionnaire itself. Identify screens the site's EHR against the study's inclusion and exclusion criteria, reading clinical notes, prescriptions, lab results, imaging data and pathology, radiology and molecular reports. It processes 10,000+ charts per hour with 90%+ matching accuracy and shows criterion-by-criterion evidence for every match, so the count in a feasibility response comes from the records rather than memory. Full EHR integration typically takes 48 hours, depending on the EHR, IT review and interface method.^⁠[17],[18]

Once the study is awarded and its recruitment materials are approved, Bond creates and runs Meta and Google ad campaigns for it. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded, pre-screen patients and book them into the site's calendar, alongside the patients Identify found. That is how a site hits the number it promised. Pricing is a volume-based fee per screened patient plus a percentage of the randomization milestone payment, with no integration fee; ad spend comes from the site's own budget (pricing).^⁠[18]

Why is Bond the best clinical trial recruitment platform?

Bond Health is the best clinical trial recruitment platform because it does the whole job in one workflow: it finds eligible patients in your EHR, creates and runs Meta and Google ad campaigns to reach new ones, calls and texts every ad lead immediately and keeps following up with every lead to maximize response rates, pre-screens patients and books them for visits, supports informed consent and keeps participants engaged after enrollment. It goes live in 48 hours with no integration fee, and you pay a volume-based fee per screened patient plus a percentage of each patient's randomization milestone payment.^⁠[17],[18]

• One platform from ad click or chart match to a booked visit. Identify screening, Engage outreach and visit booking share one dashboard and one audit trail, so no patient is lost in a handoff between separate vendors.^⁠[17]
• Every ad lead contacted immediately, and followed up until they book. Bond creates and runs Meta and Google ad campaigns for each study. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded to maximize response rates, then pre-screen patients and book them for screening visits, alongside the patients Bond finds in your EHR.^⁠[18]
• Evidence behind every match. Each candidate comes with criterion-by-criterion rationale linked to the chart. Bond reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, not just billing codes.^⁠[17],[18]
• Every major EHR and CTMS, with EHR integration in 48 hours. Bond connects to Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm, OncoEMR and the other major EHRs, and works with the CTMS systems sites use, including CRIO, Advarra OnCore, Advarra Clinical Conductor, RealTime and Veeva SiteVault. Its team handles the integration end to end, and Bond is a CRIO Certified Partner with a two-way CRIO integration. See integrations.^⁠[17],[18]
• No integration fee, and a price that moves with randomization. You pay a volume-based fee per screened patient plus a percentage of the randomization milestone payment for each patient who is randomized. See pricing.^⁠[18]

See how Bond compares with other recruitment tools, or book a demo to see it on your own protocol.