Template

Vendor evaluation checklist for AI recruitment tools

A demo on sample records tells you little about how a tool will do on your charts. This checklist is built to find out: whether the tool reads the notes where eligibility evidence often sits, shows its work criterion by criterion, fits your EHR and IRB process, and lets you leave with your data. It ends in a scoring grid you can use on every vendor, Bond included.

Last updated Sep 24, 202622 sources

What is this vendor evaluation checklist for?

Use it when a site, site network, CRO or sponsor team is choosing software that screens EHR records for trial eligibility, contacts patients, or supports consent. Send it to vendors before the demo, so the demo answers your questions instead of the vendor's.

The checklist does not replace your IRB, privacy office or contracts team. It gives them each vendor's answers in one place, in writing. Other templates cover chart review, pre-screening calls, outreach messages and IRB language.

AI recruitment vendor evaluation checklist (Word)

Word document (.docx), editable

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How do you use the checklist and scoring grid?

  1. 1

    Fill in the evaluation details

    Name the studies and EHR in scope and who will score. Include IT, the privacy office and a coordinator who does chart review today.

  2. 2

    Set the weights before any demo

    Adjust the weights in the scoring grid to your priorities. Changing them after the demos tends to favor the vendor people liked best.

  3. 3

    Send the checklist in writing

    Ask each vendor to answer every item in writing, with documents attached. An answer that exists only on a slide scores low.

  4. 4

    Run the demo on your criteria

    Pick three or four of your hardest criteria, including one that can only be settled from the notes. Ask the vendor to show the evidence behind each decision.

  5. 5

    Validate before you commit

    For finalists, run a validation or paid pilot on your own records, under a signed BAA and your approved HIPAA pathway, adjudicated by your coordinators.

  6. 6

    Score, call references, decide

    Score each area from 0 to 3 on the evidence you have seen. Call references last, with the specific gaps the grid exposed.

Part A. Evaluation details

Evaluation details

Site or organization

[Site name]

Studies in scope

[Protocol number, short title, therapeutic area] for each study

EHR and version

[EHR vendor, version, hosted or on-premises]

Evaluation lead

[Name, role, email]

Reviewers

Coordinator, PI, IT, privacy officer, security, compliance, contracts

Vendors under evaluation

[Vendor A], [Vendor B], [Vendor C]

Must-have requirements

Items that disqualify a vendor if missing, such as a signed BAA or a named integration path for your EHR.

Decision needed by

[Date]

What should you ask about accuracy, notes and traceability?

Structured fields alone often miss eligibility. At Brigham and Women's Hospital, a rule-based tool that used structured EHR data to find heart failure patients eligible for guideline-directed therapy was 32.1 percent accurate on manual review, and over 38 percent of its false positives came from misjudging symptomatic heart failure and medication history.⁠[7]

Benchmarks can flatter a tool. The TREC Clinical Trials Track, a common test for patient-to-trial matching, uses synthetic patient descriptions as its queries.⁠[5] In a vendor-authored 2025 study, one LLM pipeline reached 93 percent criterion-level accuracy on the n2c2 2018 benchmark and 87 percent criterion-level accuracy on 485 real patients from 30 US sites. The authors said the real-world figure was held back when records lacked sufficient information.⁠[6] Ask for both kinds of number, reported separately.

Area 1. Accuracy on real EHR records

  • Accuracy measured on real EHR records, with the number of patients, sites and studies in the test set stated.
  • Benchmark results (such as n2c2 or TREC) reported separately from real-world results, never blended into one headline figure.
  • The metric defined: patient-level or criterion-level, and whether it is accuracy, sensitivity (eligible patients found) or precision (flagged patients who were truly eligible).
  • A validation run on a sample of your own records before go-live, adjudicated by your coordinators, with the pass threshold agreed in writing.
  • Results by subgroup, such as age, sex, race and ethnicity, language and insurance, or a written description of how bias was tested.
  • A plan for monitoring accuracy after go-live and re-validating after each protocol amendment.

Bias testing is a reasonable ask. A 2026 JAMIA study of nine LLMs screening clinical vignettes against 58 trial protocols, 5.3 million evaluations in all, found eligibility judgments largely stable across patient identities, with homelessness producing the largest negative shift.⁠[8] A vendor should be able to say how its own tool was tested.

Area 2. Unstructured notes

  • The note types the tool reads: progress notes, history and physicals, discharge summaries, pathology and imaging reports, outside records and scanned documents.
  • How notes reach the tool at your site, for example FHIR document resources, HL7 feeds or a data warehouse extract, and which note types that path leaves out.
  • How it handles negation, family history, resolved conditions and dates, for example "no history of MI" or "mother had breast cancer".
  • A live demo on a criterion you choose that can only be settled from the notes.
  • An explicit "not enough information" result when the chart does not answer a criterion, instead of a guess.

Area 3. Criterion-level traceability

  • A decision for every criterion on every candidate: met, not met, or unknown.
  • A link from each decision to the source document, its date and the passage the tool relied on.
  • Coordinator overrides, with a reason, saved in an audit log.
  • A readable record of how each criterion was configured, with a change log a monitor can follow.
  • Advance notice of model or prompt changes, and re-validation before they reach your studies.
  • An audit trail you can export for a sponsor or monitor.

What should you ask about integration, security and patient contact?

Area 4. EHR integration path and timeline

Integration decides whether a tool gets used. A 2014 systematic review of 79 recruitment support systems concluded that success depends more on workflow integration than on sophisticated reasoning algorithms.⁠[11] The technical path is better than it was: certified health IT developers had to roll out standardized FHIR APIs by the end of 2022, and ONC reported in 2023 that more than 95 percent of them met the deadline.⁠[12] The EHR recruitment guide covers the options.

  • The named integration method for your EHR and version: FHIR API, HL7 v2 interface, scheduled export, or an integration partner.
  • What your IT, security and EHR analyst teams must provide, with an estimate of their time.
  • A written timeline from signature to first live match list, separating dependencies your site owns from those the vendor owns.
  • Whether a pilot can start before full integration, for example with list-based outreach.
  • Where coordinators work: inside the EHR, in a vendor dashboard, or in your CTMS, and how status updates flow back.
  • Systems at your site the vendor has connected to before, such as your CTMS, eRegulatory system or scheduling.

Area 5. PHI, BAA and security

A vendor that receives or maintains PHI on your behalf, for example to analyze charts, is a HIPAA business associate and needs a business associate agreement.⁠[13]

  • A signed BAA before any PHI is shared, on your paper or reviewed by your privacy office.
  • Where PHI is stored and processed, every subprocessor including any LLM provider, and whether PHI is used to train models.
  • Evidence of controls: encryption in transit and at rest, role-based access, SSO, audit logging and penetration testing, backed by a report, trust center or completed questionnaire.
  • The data elements pulled from the EHR, and whether scope can be limited to the minimum each study needs.
  • Incident and breach notification terms in the contract.
  • Your organization's security questionnaire, completed and reviewed by your security team.

Area 6. Patient disclosure and human escalation

State AI disclosure laws differ. As of September 2026, California requires health facilities, clinics and physician practices that use generative AI for patient communications about clinical information to include an AI disclaimer and instructions for reaching a human, unless a licensed or certified provider reads and reviews the message.⁠[16] Texas, since January 1, 2026, requires providers to disclose AI used in relation to health care services, in plain language, no later than when the service is first provided.⁠[17] Ask your counsel which rules reach your outreach.

  • Every call and message says, at the start and in plain language, that AI is being used.
  • A way for patients to reach a person at any point, and a demonstration of the handoff to your staff.
  • Scripts configured per study, submitted to your IRB, and locked so approved wording does not change without re-approval.
  • Escalation rules for clinical questions, adverse event reports, distress and self-harm statements, with a named site contact for each.
  • Opt-out handling that works across calls and texts and carries over between studies.
  • A review of state AI disclosure laws where your patients live, confirmed by your counsel.

What should you ask about IRB support, pricing, references and exit?

Area 7. IRB materials support

  • A plain-language description of the tool, the data it uses and who sees what, ready for the IRB application.
  • Scripts, message text and consent-support content delivered as documents your IRB can review and stamp.
  • Help choosing and documenting the HIPAA pathway: review preparatory to research, a waiver or alteration of authorization for recruitment, or patient authorization.
  • Experience with your IRB of record, local or central.
  • Committed turnaround for changes the IRB requests, stated in writing.

The IRB submission language template has sample wording for AI outreach that you can ask a vendor to fill in.

Area 8. Pricing alignment

  • Every fee in writing: setup, platform, per-patient and per-milestone.
  • A definition of each billable event: referral, pre-screen passed, consent signed, or randomization.
  • Who pays: the site, the sponsor or the CRO, and which budget the fee comes from.
  • What happens to fees if a study closes early, enrollment pauses or the protocol changes.
  • Whether fees track activity (messages, lists, referrals) or outcomes (enrolled patients), and what each means for your budget if enrollment is slow.
  • Per-patient fee terms reviewed by your compliance office and counsel.

Area 9. References

  • References from sites like yours: same EHR, similar size and therapeutic area.
  • At least one reference that has run more than one study with the vendor.
  • Permission to ask references for their own measured results, not the vendor's case study.

Reference call questions

Reference site and contact

[Name, role, site]

Studies, EHR and time live with the vendor

How long from contract to the first live match list, and what slowed it down?

How often did coordinators disagree with the tool, and what did the vendor change?

What did patients say about AI outreach? Any complaints or opt-out spikes?

What did your IRB ask for, and did the vendor supply it?

Would you sign again? What would you change in the contract?

Area 10. Exit and data ownership

HIPAA requires a business associate contract to provide that, at termination and if feasible, the vendor returns or destroys the PHI it still holds and keeps no copies.⁠[14] Match lists, audit logs and other derived data need their own clause.

  • Written confirmation that your site owns match lists, outreach records and audit logs.
  • Export of your data in a named format on termination, at no extra charge.
  • Return or destruction of PHI at termination, with written certification.
  • A clear answer on whether de-identified or derived data can be kept or used for training after you leave.
  • A handoff plan for patients who are mid-referral when the contract ends.
  • Termination for convenience and renewal terms your contracts team accepts.

How do you score vendors side by side?

Score each area from 0 to 3 using the rubric, multiply by the weight, and add up the weighted scores. Treat any 0 on a must-have from Part A as a disqualifier, whatever the total.

Part B. Scoring rubric
ScoreMeaningTypical evidence
3Shown on your records or committed in the contractValidation report on your sample, signed BAA, contract clause
2Documented in writing for a comparable settingWritten answer with the test set described, completed security questionnaire, sample IRB packet
1Claimed but not shownSlide, verbal answer, marketing page
0Missing, refused or contradictedNo answer, "proprietary", or a reference who contradicts the claim
Part C. Scoring grid
AreaWeight[Vendor A][Vendor B][Vendor C]Evidence seen
Area 1. Accuracy on real EHR records3
Area 2. Unstructured notes3
Area 3. Criterion-level traceability3
Area 4. EHR integration path and timeline2
Area 5. PHI, BAA and security3
Area 6. Patient disclosure and human escalation2
Area 7. IRB materials support2
Area 8. Pricing alignment2
Area 9. References2
Area 10. Exit and data ownership2
Weighted total24 (maximum score 72)

Enter score times weight in each vendor column. The weights are a starting point; change them before the first demo, not after.

What needs IRB approval when you add an AI recruitment tool?

Adding a vendor does not move responsibility. ICH E6(R3) lets the investigator delegate trial activities to other parties and service providers, but the investigator keeps the final decision on whether to use one.⁠[19] What changes is what your IRB and privacy office need to see. The HIPAA and IRB outreach guide covers each pathway in detail.

Part D. Approvals to plan for
ItemWho reviews itBasis
Outreach scripts, message text and call flows used by AI agentsIRB, before useFDA treats recruitment advertising as the start of informed consent and expects the IRB to review its content and mode of communication.⁠[18] ICH E6(R3) calls for documented IRB approval of recruitment procedures before a trial starts.⁠[19]
Pre-screening questions and how answers are storedIRBFDA expects the IRB to check that screening scripts protect prospective subjects and that sensitive information collected is handled appropriately.⁠[18]
Use of PHI to find candidates before contactIRB or privacy board, and the privacy officeHIPAA allows reviews preparatory to research, or use under an IRB or privacy board waiver or alteration of authorization.⁠[15]
How the tool decides who is contactedIRBAn FDA-regulated IRB must find that selection of subjects is equitable.⁠[20]
Consent-support contentIRBThe informed consent process is conducted by the investigator or site staff the investigator delegates.⁠[19]
Vendor contract and BAAPrivacy office, security and legalA vendor handling PHI on your behalf is a business associate.⁠[13]

How does Bond answer this checklist?

Bond is one of the vendors you can score with this grid, so hold us to the same evidence rule. Here is where our current answers live.

  • Accuracy. Our site states above 90 percent matching accuracy.⁠[1] Our technical report gives 0.9312 micro F1 on a held-out n2c2 2018 cohort-selection evaluation, a benchmark result rather than a result on your charts.⁠[3] Under the rubric, neither earns a 3 until you have seen a validation on your own records.
  • Notes and traceability. Identify reads structured and unstructured records against a study's inclusion and exclusion criteria, ranks candidates and shows the evidence behind each criterion decision.⁠[1]
  • Integration. Bond connects to all the major EHRs, including Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm and OncoEMR, through FHIR or HL7 interfaces or an aggregator.⁠[1],[2] Full EHR integration takes 48 hours, depending on your EHR, IT review and interface method.⁠[1] See implementation.
  • Security. Bond is HIPAA compliant and SOC 2 Type I compliant, and its SOC 2 Type II and ISO 27001 audits are underway.⁠[2] Bond signs BAAs and lists its controls on the security page and its Vanta Trust Center.⁠[1]
  • Disclosure. Engage tells patients that AI assistance is used, and they can reach a person at any time: the agent transfers the call live to a coordinator or books a human callback, whichever the site prefers.⁠[1],[2]
  • Pricing. A volume-based platform fee plus a success fee per enrolled patient, where enrolled means randomized. There is no integration fee. See pricing.⁠[1]

Bring this checklist and one protocol. We will walk through each area and show how Identify presents the evidence behind each criterion decision.

Frequently asked questions

Can a vendor test its tool on our patient records before we sign?
Not without a signed BAA and your privacy office's approval. A vendor that receives PHI to analyze charts on your behalf is a business associate.⁠[13] If the work is framed as research, a review preparatory to research requires a representation that no PHI will be removed from the covered entity.⁠[15] Plan for a demo on sample records first and a validation on real records after the BAA is signed.
Should we score Bond with this checklist too?
Yes. Ask us for written answers to each area for your studies, and apply the same evidence rule you use for every other vendor.

Sources

  1. 1.Bond Health: platform overview, FAQ and pricing · Bond Health, 2026
  2. 2.Bond Health product information · Bond Health, 2026Capabilities, pricing and compliance status described by Bond Health, September 2026.
  3. 3.Terminology Infrastructure and Graph-Grounded RAG for Clinical Trial Patient Matching · Bond Health, preprint, 2026Internal technical report by R. Goel, August 2026. Available on request.
  4. 4.IBM's Watson supercomputer recommended 'unsafe and incorrect' cancer treatments, internal documents show · STAT, 2018Quote: "The software was drilled with a small number of 'synthetic' cancer cases, or hypothetical patients, rather than real patient data." The internal IBM documents cite "multiple examples of unsafe and incorrect treatment recommendations" identified by company medical specialists and customers. Ross C, Swetlitz I, July 25, 2018.
  5. 5.TREC 2021 Clinical Trials Track · TREC Clinical Trials Track organizers, 2021
  6. 6.Real-world validation of a multimodal LLM-powered pipeline for high-accuracy clinical trial patient matching · Communications Medicine, 2025Quote: "On the n2c2 dataset, our method introduces a new state-of-the-art criterion-level accuracy of 93%. In real-world trials, the pipeline yielded an accuracy of 87%, undermined by the difficulty of replicating human decision-making when medical records lack sufficient information." Vendor-authored (Inato). Real-world set: 485 patients from 30 sites. doi:10.1038/s43856-025-01256-0.
  7. 7.Identifying Patients with Heart Failure Eligible for Guideline-Directed Medical Therapy · Population Health Management, 2024
  8. 8.Sociodemographic bias in large language model clinical trial screening · Journal of the American Medical Informatics Association, 2026
  9. 9.Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule, 89 FR 1192 · Federal Register / HHS Office of the National Coordinator for Health IT, 2024
  10. 10.45 CFR 170.315(b)(11) Decision support interventions · eCFR (Office of the Federal Register / GPO), 2026Quote: "(6) External validation process, including: (i) Description of the data source, clinical setting, or environment where an" and "(7) Quantitative measures of performance, including: (i) Validity of intervention in test data derived from the same source as the" (source attributes for predictive DSIs, 170.315(b)(11)(iv)(B); text current as of 2026-09-01). The paragraph's nine headings: details and output of the intervention; purpose of the intervention; cautioned out-of-scope use; intervention development details and input features; process used to ensure fairness in development; external validation process; quantitative measures of performance; ongoing maintenance of intervention implementation and use; update and continued validation or fairness assessment schedule.
  11. 11.Employing computers for the recruitment into clinical trials: a comprehensive systematic review · Journal of Medical Internet Research, 2014
  12. 12.Achieving a Major Milestone: Health IT Developers Certify to Cures Update · HealthIT.gov (ASTP/ONC), 2023
  13. 13.45 CFR 160.103 Definitions (business associate) · eCFR (Office of the Federal Register / GPO), 2026
  14. 14.45 CFR 164.504(e) Business associate contracts · eCFR (Office of the Federal Register / GPO), 2026Quote: "At termination of the contract, if feasible, return or destroy all protected health information received from, or created or received by the business associate on behalf of, the covered entity that the business associate still maintains in any form and retain no copies of such information" (164.504(e)(2)(ii)(J); text current as of 2026-09-01).
  15. 15.45 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 / GPO), 2026
  16. 16.AB-3030 Health care services: artificial intelligence (Chapter 848, Statutes of 2024) · California Legislative Information, 2024
  17. 17.H.B. No. 149, Texas Responsible Artificial Intelligence Governance Act (enrolled) · Texas Legislature Online, 2025
  18. 18.Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators · U.S. Food and Drug Administration, 1998
  19. 19.ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) · International Council for Harmonisation, 2025
  20. 20.21 CFR 56.111 Criteria for IRB approval of research · eCFR (Office of the Federal Register / GPO), 2026
  21. 21.Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (draft guidance) · U.S. Food and Drug Administration, 2025
  22. 22.FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions · U.S. Food and Drug Administration, 2025Quote: "This guidance provides a risk-based framework for sponsors to assess and establish the credibility of an AI model for a particular context of use."

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