Glossary
Clinical trial recruitment terms, defined
30 terms that come up in feasibility calls, IRB submissions and enrollment reports, each with a source and a link to where it matters in the recruitment workflow.
Last updated Sep 24, 2026
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Clinical research coordinator (CRC)
The study staff member who runs participation day to day, from pre-screening and scheduling to consent and visits, linking patient, investigator and sponsor.
Full definitionClinical trial management system (CTMS)
Software that sites, sponsors and CROs use to run studies, tracking participants, visits, staff tasks, budgets and recruitment status in one place.
Full definitionD
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EHR phenotyping
Finding patients with a specific condition or outcome in electronic health record data, using coded fields and clinical notes, by rules or machine learning.
Full definitionElectronic informed consent (eConsent)
Using electronic systems, such as tablets, web pages, video or interactive content, to present study information, check understanding and document consent.
Full definitionEnrollment rate
How fast a trial or site enrolls participants, usually expressed as patients enrolled per site per month and compared with the rate the plan assumed.
Full definitioneRegulatory binder (eISF)
A digital investigator site file that holds a site's essential regulatory records, such as approvals, logs and training, and lets monitors review them remotely.
Full definitioneSource (electronic source data)
Clinical trial data first recorded in electronic form, such as direct entry into a study system or an EHR, rather than transcribed from paper records.
Full definitionF
FHIR (Fast Healthcare Interoperability Resources)
An HL7 standard for exchanging health data as modular resources over web APIs. Certified US EHRs must offer a FHIR API that approved outside apps can connect to.
Full definitionFirst patient in (FPI)
The milestone when the first participant enrolls in a study or at a site. Sponsors watch the time from site activation to first patient in closely.
Full definitionH
HIPAA authorization
A patient's signed permission for a covered entity to use or share their health information for a purpose, like research, that HIPAA does not otherwise allow.
Full definitionHL7 (Health Level Seven)
The standards organization behind the HL7 v2 messages, CDA documents and FHIR APIs that most EHRs use to exchange data with other systems.
Full definitionI
Inclusion and exclusion criteria
The protocol rules that decide who can join a trial: inclusion criteria every participant must meet, and exclusion criteria any one of which rules a person out.
Full definitionInformed consent
The process through which a person learns about a trial, asks questions and voluntarily agrees to join. The signed form documents it but does not replace it.
Full definitionInstitutional review board (IRB)
The committee that reviews and approves human research, including recruitment materials and outreach scripts, to protect participants' rights and welfare.
Full definitionL
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Pre-screening
Checking whether a person might qualify for and want to join a study before they sign consent, through a records review or a short conversation.
Full definitionPrincipal investigator (PI)
The person responsible for a study's scientific and technical direction and, at a site, for its conduct, staff and participants, even when tasks are delegated.
Full definitionProtocol deviation
Any departure from the processes or procedures a study protocol defines, from a visit outside its window to enrolling someone who missed a criterion.
Full definitionR
Randomization
Assigning trial participants to treatment groups by chance to reduce bias. In many studies, randomization is also when a participant counts as enrolled.
Full definitionReviews preparatory to research
A HIPAA pathway that lets researchers review records to prepare a protocol or check feasibility without authorization, if no PHI leaves the covered entity.
Full definitionS
Screen failure rate
The share of patients who sign consent and start screening but do not qualify for randomization, usually because a protocol criterion is not met.
Full definitionScreening
The period after a participant signs consent when study procedures confirm whether they meet every eligibility criterion before enrollment or randomization.
Full definitionSite activation
The point at which a selected site has finished contracts, budget, IRB approval and training, and the sponsor authorizes it to start enrolling participants.
Full definitionSite feasibility assessment
How sponsors and CROs check whether a site can run a specific trial: its patient population, staff, equipment, competing studies and past enrollment.
Full definitionStudy start-up
Everything between choosing sites and enrolling the first patient: site identification and selection, contracts, budgets, IRB review, documents and activation.
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