Template
Feasibility questionnaire template for research sites
Sponsors and CROs send a feasibility questionnaire before they shortlist a site, and many cover the same ground in a different order. This template puts those questions in one place so your site can answer once, keep the answers current, and copy them into each sponsor's form. It includes a worksheet for patient counts drawn from your EHR, because a count with its method attached is easier to believe than an estimate.
What is this feasibility questionnaire for?
A feasibility questionnaire is how a sponsor or CRO decides whether your site can run a study and enroll for it. In a 2024 ACRP blog post, one site leader put these forms at anywhere from 10 to 40 pages.[1] Sites are typically not compensated for feasibility work, according to a 2024 paper by an industry task force of sites, site networks, sponsors and CROs. The same paper cites an estimate, extrapolated from oncology survey data, that the burden and inefficiency of site feasibility cost the industry $1.6 billion.[2]
11%[3]
of sites in a typical trial enroll no patients
37%[3]
of sites enroll fewer patients than planned
$1.6B[2]
estimated industry-wide cost of feasibility inefficiency, extrapolated from oncology
The sponsor's caution has a basis. Those site-performance figures come from a Tufts CSDD analysis of more than 150 studies and nearly 16,000 sites, released in January 2013.[3] The questionnaire is the sponsor's first attempt to tell the sites that will enroll from the ones that will not.
Use this template as your site's master answer file. Fill it in once per therapeutic area, update it each quarter, and paste from it when a sponsor's form arrives. The guide to how sponsors choose sites explains what happens to your answers after you send them.
Feasibility questionnaire template (Word)
Word document (.docx), editable
How should your site use the template?
- 1
Fill in the standing sections once
Site profile, staff, experience, equipment and timelines change slowly. Complete them now and have the site director review them.
- 2
Run the patient count for each protocol
The patient population section depends on the protocol's criteria. Rerun the EHR query for each synopsis and record the query date.
- 3
Check competing studies
List every open or planned study at your site that draws on the same patients, including investigator-initiated work.
- 4
Have the PI review it
The sponsor will hold the principal investigator to the enrollment estimate. The PI should see the count, the method and the projection before the form goes out.
- 5
Keep a dated copy
Save each completed response with the date and the sponsor's version. When the study starts, compare actual enrollment against what you projected.
What goes in the site profile, staff and experience sections?
These answers change slowly, so they can be reused across sponsors. Replace the bracketed text with your own details.
Section A. Site profile
Site name and address
[Site name], [street address], [city, state, ZIP]
Site type
Options: Independent research site / Site network member / Academic medical center / Hospital or health system / Physician practice / FQHC or community health center
Principal investigator
[Name, credentials, specialty, board certification]
Primary contact for this study
[Name, role, email, phone]
IRB of record
If a local IRB is required, give its meeting schedule and usual turnaround.
Options: Central IRB accepted / Local IRB required / Either, depending on the sponsor
Electronic systems in use
EHR vendor, CTMS, eRegulatory or eISF, eSource. Note which sponsor systems your staff already use.
Patient catchment
Clinics, referral partners and counties your site draws from.
Section B. Staff
Investigators
PI and each sub-investigator: [name], [specialty], [studies as PI or sub-investigator in the past three years], [GCP training date].
Study coordinators
Number of coordinators, time each devotes to research, and current study load per coordinator.
Regulatory, data entry and pharmacy support
Named roles, and whether each is in-house or shared.
Languages spoken by consenting staff
Languages in which staff can hold the consent discussion without an interpreter.
Staffing changes expected during the study
Planned hires, departures or leave.
Section C. Experience
Studies in this therapeutic area, past three years
For each: phase, indication, sponsor or CRO, enrollment commitment, patients randomized, status.
Enrollment against commitment for closed studies
Randomized versus committed for each study that closed in the past three years. Give a reason next to any shortfall.
Screen failure rate on similar studies
Screen failures divided by patients screened, with the top reasons.
Audit and inspection history
FDA inspections and sponsor audits, with outcomes and any Form FDA 483 observations.
Sponsors weigh this history for a reason: sites with a track record of successful enrollment are more likely to meet their targets.[6] Systems count too. Florence's 2024 State of Technology Enabled Clinical Trials report, as cited in WCG's 2024 site survey report, found that 43% of sponsors view a site's adoption of the sponsor's software as a key selection criterion, so list the sponsor platforms your staff already know.[4]
How should you report the patient population?
A diagnosis-code count is not a count of eligible patients. The worksheet below turns one into the other in steps, so the sponsor can see which inclusion and exclusion criteria you applied and which you could not check in the chart.
| Step | Criteria applied | Data source | Patients remaining |
|---|---|---|---|
| Diagnosis | [ICD-10-CM codes or problem-list terms for the condition] | Problem list, encounter diagnoses | [n] |
| Active at your site | Seen at [site] within [lookback window] | Encounters | [n] |
| Age and sex | [Protocol age range and sex criteria] | Demographics | [n] |
| Key labs and measures | [Lab thresholds, vitals or scores the protocol requires] | Lab results, vitals, flowsheets | [n] |
| Prior and current therapy | [Required or excluded medications and washout periods] | Medication lists, orders | [n] |
| Major exclusions | [Conditions or events that exclude] | Problem list, notes, reports | [n] |
| Chart-reviewed sample | [n] charts reviewed by [role]; [n] held up | Coordinator review | [n] |
Record the query date, the lookback window and who ran the query. Criteria the chart cannot answer, such as willingness to follow the visit schedule, belong in the pre-screening call, not the count.
Section D. Patient population
Query date and method
[Date], [who ran it], [EHR report, data warehouse or screening software]
Final count from the worksheet
Criteria you could not check in the EHR
List them. These are checked at pre-screening or screening.
Demographic breakdown of the final count
By race, ethnicity, sex and age group, where the data allows. Note fields that are often blank.
New patients per month who meet the key criteria
From new diagnoses or referrals over a recent period. State the period.
Projected randomizations per month
Apply your historical consent and screen failure rates to the final count and to new patients per month, over the planned enrollment period. Show the arithmetic.
Recruitment sources beyond the EHR
Referral partners, registries, community outreach, IRB-approved advertising.
What should you report on competing studies, equipment and timelines?
Section E. Competing studies
Open studies that draw on the same patients
[Sponsor or protocol], [phase], [status], [where the criteria overlap]
Planned studies now in start-up
Same details as above.
How you would prioritize referrals
Which study gets first referral when a patient qualifies for more than one.
Section F. Facilities and equipment
Dedicated exam rooms for research visits
Locked, access-controlled storage for investigational product
Temperature-monitored refrigerator and freezer with alarms and logs
Ultra-low temperature freezer, if the protocol requires one
Refrigerated centrifuge
Investigational pharmacy or pharmacist oversight
ECG machine with calibration records
On-site or contracted imaging: [modalities]
Staff trained to ship biological samples as dangerous goods
Remote monitoring access to the EHR or eSource
Other protocol-specific equipment
[List, with calibration or maintenance dates]
Section G. Start-up timelines
Budget and contract review
Median days from receipt to signature on recent studies, and who reviews: the site, the institution, or both.
IRB review
Central IRB reliance steps, or local IRB meeting frequency and median days to approval.
Earliest site initiation visit
[Date staff can attend]
Activation to first patient screened
Median days on recent studies.
Blackout dates
Holidays, staff leave or audits during the projected enrollment period.
| Measure | Published benchmark | What to report |
|---|---|---|
| Activation to first patient screened | Median 20 days; top quartile 8 days, bottom quartile 34 days, in a CRIO analysis for SASI published July 2026[5] | Your median across recent studies |
| Start-up at independent sites and physician practices | 60% reported starting studies in under 60 days in WCG's 2024 site survey[4] | Your median from contract receipt to activation |
| Start-up at academic medical centers, community hospitals and health systems | 77% reported start-up longer than 60 days in the same survey[4] | The same measure, split into budget, contract and IRB |
If your numbers are slower than these, give the reason next to them. A sponsor trusts an explained delay more than an unexplained one.
What should the budget section ask?
Some questionnaires ask about budget expectations before a draft budget exists. State your standard fees and terms now so the negotiation starts from your numbers.
Section H. Budget expectations
Start-up fee
[Amount], non-refundable, invoiced at [contract signature or activation]
IRB fees
Initial review, continuing review and amendments, if not paid directly by the sponsor.
Pharmacy fees
Set-up, dispensing and close-out.
Per-patient visit costs
From your research rate sheet for the procedures in the schedule of assessments.
Screen failure reimbursement
A fee per screen failure, or the ratio of screen failures paid per randomized patient.
Pre-screening and recruitment costs
Chart review, patient outreach, advertising and any recruitment vendor fees.
Coordinator time outside visits
Feasibility, start-up, monitoring visits, query resolution and close-out.
Overhead or indirect rate
[Rate], applied to [which costs]
Payment terms
Invoice frequency and the days to payment you require.
Holdback
The share withheld until database lock, if any, and whether you accept it.
Does any of this need IRB approval?
Completing the questionnaire itself generally does not: it describes your site, not a study procedure, and no patient is contacted. Two activities around it need care, and your IRB and privacy office have the final word on both.
- Running the EHR count. Reviewing records to judge whether a study is feasible is usually handled under the HIPAA provision for reviews preparatory to research. The covered entity must obtain the researcher's representation that the review is solely to prepare a research protocol or for similar purposes preparatory to research, that no protected health information will be removed from the covered entity, and that the information is necessary for the research.[7] Send the sponsor aggregate counts only, and follow your privacy office's rules on who may run queries.
- Contacting patients to test interest. That is recruitment, not feasibility. FDA's recruiting guidance (issued January 1998 and posted on its website as of September 2026) treats direct advertising for study subjects as the start of the informed consent and subject selection process, and says advertisements should be reviewed and approved by the IRB.[8] Wait until the study, its recruitment materials and any outreach scripts are approved.
The guide to IRB and HIPAA rules for patient outreach covers the outreach side in detail.
Where does Bond fit?
Bond Health does not fill in feasibility questionnaires. It helps with the part that depends on chart review: the patient count. Identify reads structured and unstructured EHR records against a study's inclusion and exclusion criteria, ranks candidates, and shows the chart evidence behind each criterion decision. A coordinator can check a sample of those decisions before the site reports a number, which is the chart-reviewed step in the worksheet above. Full EHR integration usually takes 48 hours, depending on the EHR, IT review and interface method.[9]
Once a study is awarded and its recruitment materials are IRB-approved, the same candidate list can feed Engage for outreach and scheduling, so outreach starts from patients already screened against the criteria. See Bond for research sites, or browse the other templates.
Bring a protocol synopsis you are evaluating and see Bond screen records against its criteria, with the chart evidence for each decision.
Frequently asked questions
Are sites paid to complete feasibility questionnaires?
Can we share patient counts with a sponsor before the study is approved?
How often should we update the template?
What if a sponsor's form asks something this template does not cover?
What if we cannot run an EHR query ourselves?
Sources
- 1.Fixing Feasibility: Collaborative Approaches for Redefining and Improving Site Selection · Association of Clinical Research Professionals (ACRP), 2024Blog post quoting Nancy Sacco, SiteBridge Research: "feasibility questionnaires can be anywhere from 10 to 40 pages." Site-leader testimony, not a survey.
- 2.Redefining feasibility in clinical trials: Collaborative approaches for improved site selection · Contemporary Clinical Trials Communications, 2024Site Enablement League Task Force; Florence Healthcare employees manage the league. Quotes: "sites are typically not compensated for feasibility assessment work"; "the scale of the problem across the industry is estimated at $1.6B", citing a Clinical Leader article and extrapolated from ASCO oncology survey results.
- 3.New Research From Tufts Center for the Study of Drug Development Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices · Tufts Center for the Study of Drug Development, press release via BioSpace, 2013Released January 15, 2013. Quotes: "11% of sites in a given trial typically fail to enroll a single patient"; "37% under-enroll". Analysis of more than 150 studies and nearly 16,000 sites; global, pre-2013 data.
- 4.2024 Clinical Research Site Challenges Report · WCG Clinical, 2024Survey of 852 sites, April to June 2024. Quotes: budgets and contracts were "the main offenders contributing to delayed study start-up timelines, affecting 69% of respondents"; independent sites and physician practices, "60% reporting that they can initiate studies in under 60 days"; academic medical centers, community hospitals and health systems, "77% saying their study start-up timelines exceed 60 days"; "43% of sponsors view their software's adoption as a key selection criterion", cited from Florence's 2024 State of Technology Enabled Clinical Trials report.
- 5.What It Takes to Start a Study: Site Start-up Benchmarks · CRIO, 2026Quote: "The median time from activation to first patient screened is 20 days, but top-quartile performance is observed at just 8 days, or a little over a week. Bottom-quartile performance is 34 days, or just over a month." Analysis performed for the Site Accreditation and Standards Institute (SASI); sample size not stated.
- 6.Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review · Contemporary Clinical Trials Communications, 2018Quote: "Study centers with a track record of successful performance are historically more likely to meet enrollment targets."
- 7.45 CFR 164.512: Uses and disclosures for which an authorization or opportunity to agree or object is not required · eCFR, Office of the Federal Register, 2026Paragraph (i)(1)(ii), reviews preparatory to research. Quote: "No protected health information is to be removed from the covered entity by the researcher in the course of the review." Accessed September 2026.
- 8.Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators · U.S. Food and Drug Administration, 1998Issued January 1998. Quotes: "FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process." "Advertisements should be reviewed and approved by the IRB as part of the package for initial review."
- 9.Bond Health: platform overview, FAQ and pricing · Bond Health, 2026
Related pages
How sponsors choose sites
What sponsors check during selection and how they read your answers.
ReadHow to win more studies
Building the sponsor and CRO relationships that bring repeat studies.
ReadIdentify: LLM-based EHR screening
Criterion-level matching against your records, with the chart evidence shown.
ReadBond for research sites
How sites use Bond for screening, outreach and consent support.
ReadAll templates
Editable templates for feasibility, pre-screening, outreach and IRB language.
Read