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How we validate eligibility logic before go-live

An AI screening tool is only as good as the criteria it was given and the evidence it can find. This post describes what happens between signing and go-live: how a protocol's inclusion and exclusion criteria become checks the system can run, how those checks are tested against real records, and what a coordinator sees when a match is wrong.

By Rishabh Goel · Sep 21, 2026 · 6 min readLast updated Oct 5, 20263 sources
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Why validate at all?

Eligibility criteria are written for humans. A line like "no myocardial infarction within the past three months" assumes a reader who can find a discharge summary, read a date, and decide whether a troponin bump in an emergency note counts. When software makes that decision, someone has to check that it makes it the way the study team would. Bond does that before go-live, on the site's own records, with the site's own coordinators, so that the first live match list is one the team already trusts.⁠[1]

How are criteria turned into checks?

Each criterion in the protocol is broken into the clinical concepts it refers to, the evidence that could establish it, and the time window that applies. The Identify stage links those concepts to Bond's terminology graph so that the many ways a chart can say the same thing, a diagnosis code, a medication, a phrase in a note, all resolve to one check.⁠[2]

  1. 1

    Read the protocol with the study team

    Ambiguous criteria are flagged and resolved with the coordinator or PI before anything is configured. "Adequate organ function" gets the lab thresholds the sponsor actually uses.

  2. 2

    Map each criterion to evidence types

    Structured fields such as problem lists, labs and medications are the first source. Notes, pathology and imaging reports are the second. Each criterion records which sources can satisfy it and which can only suggest it.

  3. 3

    Set time windows and precedence

    A resolved diagnosis, a discontinued drug, or a lab from two years ago should not count. Each check carries the window from the protocol and a rule for conflicting evidence.

  4. 4

    Decide what needs a human

    Some criteria cannot be settled from the chart, for example willingness to use contraception. Those are marked for the pre-screening call rather than the screening pass.

How is the configuration tested against real records?

Once criteria are configured, Bond runs them against a sample of the site's records under the site's business associate agreement and its IRB or privacy board determination for preparatory-to-research review. The output is not a list of eligible patients. It is a list of decisions, one per criterion per patient, each with the evidence the system relied on and a link back to where in the chart it found it.⁠[1]

  • Coordinators review a stratified sample: clear matches, clear exclusions, and the uncertain middle where most errors live.
  • Every disagreement is logged with the reason: wrong evidence, right evidence but wrong interpretation, missing evidence, or a criterion the team decided to change.
  • Criteria are adjusted and the sample is re-run until agreement meets the study's threshold. Changes are versioned so a monitor can see what was live on any date.

This is the same loop a good coordinator runs in their head when they train a new colleague. Making it explicit is what lets the site sign off on the logic rather than on a demo.

What happens after go-live?

Validation does not stop at launch. Each match the coordinator accepts or rejects in the dashboard feeds back into the study's accuracy report. When the protocol is amended, the affected criteria go through the same configure and test loop before the new version screens anyone. Screen failures at the site are reviewed against the pre-screening decision to catch causes the chart could have predicted.⁠[1]

What the site sees at each stage
StageSite's roleBond's output
ConfigurationResolve ambiguous criteria with the study teamCriterion-by-criterion checklist with evidence types and windows
Validation runAdjudicate a sample of decisionsPer-criterion agreement, error reasons, versioned criteria
Go-liveReview ranked matches in the dashboardMatch list with criterion-to-evidence rationale
AmendmentsApprove re-validated criteriaChange log and a fresh validation report

Bring one protocol, and we will walk through how Bond would screen its hardest criteria.

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.⁠[1],[3]

  • 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.⁠[1]
  • 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.⁠[3]
  • 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.⁠[1],[3]
  • 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.⁠[1],[3]
  • 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.⁠[3]

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

Frequently asked questions

Does the site have to share PHI before the contract is signed?
No. A demo needs no patient data. Validation on real records happens after the business associate agreement is in place and the site's IRB or privacy board has made the relevant determination, as described on the security page.
Who decides what an ambiguous criterion means?
The study team does. Bond documents the interpretation so it can be shown to the sponsor or monitor, but the site and the sponsor own the protocol.

Sources

  1. 1.Bond Health: platform overview, FAQ and pricing · Bond Health, 2026
  2. 2.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.
  3. 3.Bond Health product information · Bond Health, 2026Capabilities, pricing and compliance status described by Bond Health, October 2026.

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