Clinical trial recruitment calling playbook for study teams

What this playbook covers

Trial recruitment calling succeeds inside constraints that are not negotiable: the IRB gates the script and the channel, the protocol limits contact, the privacy rules govern the data path, and the study team owns eligibility. This playbook covers the gating sequence, block structure, cadence, screening boundaries, dispositions, the three-line workflow, and KPI ranges against production reference points.

Gating: what must exist before the first dial

Nothing enters the dialer before the packet is complete:

1. IRB approval covering the recruitment methods, the advertisement, the script, the screening questions, and the way contact information is obtained and recorded. Recruitment is part of the research activity.
2. The PHI path: where the list carries protected health information, 45 CFR 164.502 permits research use only as that subpart allows, 45 CFR 164.508 or an IRB-approved waiver under 164.512(i) governs authorization, and vendors storing or processing PHI operate under a business associate agreement.
3. Protocol contact limits, which override the playbook’s defaults wherever stricter.
4. Sponsor requirements, which run on top of everything above.

The queue mirrors the packet row by row: source channel, approved language version, protocol window. A queue without its packet is a compliance incident waiting for a recording.

Call block structure

Late morning block, 10:00 to 12:00 patient-local. Patients answer after morning routines and appointments; the coordinator’s calendar sits adjacent so prescreens book same-day where possible.

Early evening block, 5:00 to 7:00. Working patients and caregivers home from work; the second booking window.

Prescreen confirmation window, daily. Confirmations and written notices go out from the site identity, never from a personal phone.

All calls respect 8 a.m. to 9 p.m. patient-local hours under 47 CFR 64.1200(c)(1) and any narrower protocol window. Three lines per recruiter, one connect at a time; a recruitment call is never rushed to the next ring.

Attempt cadence

Default four touches, protocol limits first:

1. Day 1. The IRB-stated opener and approved screener.
2. Day 3, different daypart. The catch window for working patients.
3. Day 7. Voicemail in approved language, site identity clear, callback number the site controls.
4. Day 10, final. Last live attempt with the honest close and the site’s public information path.

A stated stop ends the campaign that hour, on every list the person appears on. Ineligible-by-stated-criteria rows exit permanently; the record notes that no determination was made, because the phone screen does not determine anything.

Dispositions and what they mean

• Screening scheduled: coordinator slot, written confirmation with study description and privacy notice.
• Asked for study information: public materials sent per the approved channel; the recruiter does not freelance the science.
• Not interested: logged with wording; recontact only if the IRB-approved plan says so.
• Ineligible by stated criteria, no determination made: the row exits; the caveat stays on the record.
• Referred to study team: questions the recruiter must not answer, routed the same day.
• Do not contact / Wrong number: suppression before the next block.

The three-line workflow and AI summaries

Three lines fit recruitment only when connects are handled with presence: one call at a time, approved language spoken, the consent block stated, the AI summary edited before the next dial. The summary carries the approved screening answers, the recording OK, the booked prescreen, any caregiver notes and any stop request with its exact wording. Summaries export into the study record and follow the protocol’s retention rules, not the floor’s habits. Recording disclosure on everywhere; several states require all parties to consent before recording.

KPI targets

Ranges against production reference points. In production use across 3-line sessions over 90 days, the median operator ran about 85 dials per active hour and roughly 600 dials per operator day, with person connects around 17.8 percent. Planning ranges for recruitment:

• Dials per active hour: 50 to 80; trust conversations run longer than sales connects by design.
• Patient reaches: 10 to 20 percent depending on channel quality; referral channels beat public-record channels on every metric that matters.
• Prescreens booked: 10 to 20 per 100 patient reaches on strong channels.
• Prescreen completion: 60 to 80 percent with same-day written confirmations.
• Do-not-contact rate: tracked by channel; a rising rate is a channel problem, not a script problem.

These figures are measured in production use, 3-line sessions, 90 days; they are reference points, not a promise of results.

Counsel review notice

This is a counsel-review-first category. The IRB approves the recruitment methods, script and contact handling before the first block; privacy counsel reviews the PHI path, the business associate agreement and the recording practice; the sponsor’s requirements run on top of all of it. This guide describes rules, not compliance advice, and no block runs ahead of those approvals.

Compliance in one paragraph

Recruitment is part of the research activity: 45 CFR 46.116 governs the informed consent process, the IRB approves the methods and script, and the protocol owns contact limits. Protected health information runs under 45 CFR 164.502 with authorization or waiver under 45 CFR 164.508 or 164.512(i), and a business associate agreement is expected for vendors touching PHI. TCPA wireless restrictions apply under 47 CFR 64.1200(a)(1), hours run 8 a.m. to 9 p.m. local under 64.1200(c)(1), and several states require all-party recording consent. DialBreeze places calls and takes notes; it does not obtain consent, determine eligibility, or manage the protocol record.