Clinical trial recruitment phone script for prescreening

The boundary that shapes every line

Clinical trial recruitment is a C fit, and the constraint is the design: recruitment is part of the research activity, so the script, the questions and the contact method belong to the IRB before they belong to the floor. Under 45 CFR 46.116, an investigator must obtain legally effective informed consent before involving a person in covered research, and the process must give the person enough opportunity to consider participation and minimize coercion. Where protected health information is involved, 45 CFR 164.502 permits use for research only as that subpart allows, and 45 CFR 164.508 or an IRB-approved waiver under 45 CFR 164.512(i) governs authorization.

What that means on the phone: the rep identifies the study, runs only approved questions, states the recording and privacy language, books a prescreen with the coordinator, and never determines eligibility, never interprets the protocol, never minimizes risk, and never improvises answers about how the person was contacted.

The structure

The IRB-stated opener. Site name, study area, the sentence that the study’s details are IRB approved, and the permission check. Nothing is being sold, because nothing is; stating it is still required by the script, not optional.

The two approved screener questions. Current treatment for the condition and the protocol age floor, exactly as approved, with the boundary sentence attached: the rep cannot determine qualification; the study team does. The boundary sentence is not a disclaimer; it is the design.

The consent-to-record block. What is recorded, why, and how information is handled under the site’s privacy practices, with an explicit OK before booking. Several states require all-party consent to record; the script carries the language because fine print does not consent.

The two-slot close. Prescreen times with the coordinator, written confirmation with the study description and privacy notice, and the honest note that a not-a-fit outcome is normal.

Objection handling

“Is this a scam?”

Skepticism is the correct posture and the script honors it with verifiable structure: “You can verify the study independently: the IRB approval means an ethics board reviewed it, the site’s name is [site], and the coordinator will give you the study description in writing before anything else happens. You can also decline at any point, including right now, and I will close your file today.” Never argue; hand over the verification path.

“How did you get my number?”

Only the approved answer: “Your information came to us through [approved channel per the IRB approval].” If the person objects to the channel, apologize, log do-not-contact, and stop. Improvised sourcing answers are prohibited on this campaign; the approved language exists for this exact question.

“I don’t want to be a guinea pig”

“That phrase is exactly why the process is built the way it is: informed consent means you hear the risks, the alternatives and the unknowns from the coordinator, in plain language, before you decide anything. Prescreening does not enroll you in anything; it is a 15 minute conversation.” Facts about the consent process, never minimization of risk.

“Can you tell me if I qualify?”

“I cannot, and here is why that protects you: eligibility is a medical and protocol determination made by the study team with your history in front of them. What I can do is book the 15 minute prescreen where that determination is made properly, with the chance to ask everything.” The boundary is the pitch.

“My husband handles my medical decisions”

“Then he should be part of the prescreen; bring him on the call or to the appointment. Nothing proceeds without the right people comfortable, and the coordinator will answer his questions too.” Bring caregivers in, never around them; the consent process expects the people who matter.

“Who is paying for this study?”

“The sponsor is [sponsor per approved language], and the site is paid to conduct the study; the coordinator will explain what costs the study covers and what it does not, in writing, at the prescreen.” Answer from the approved language only, and route the rest to the coordinator.

Caregiver and third-party calls

Calls often reach a family member first. Keep it to identification and the study description; no condition details, no screening questions, no prescreen booking on behalf of the person without their participation. The third party gets the callback number and the study’s public description. Anything more runs into the privacy rules that 45 CFR 164.502 governs, and the script’s design keeps it out of reach.

Voicemail, 20 seconds

“Hello, this is [name] calling from [research site] about a research study for [condition area] that was reviewed by an Institutional Review Board. This is not a sales call; taking part is voluntary at every step. Our coordinator can explain the study in a short prescreen; I will try you [day], or the site’s number is [number].” Approved language, no condition specifics beyond the study area, no urgency.

After the call

The AI summary should carry the approved screening answers, the recording OK, the booked prescreen, and any do-not-contact request with its exact wording. Dispositions match the trade: screening scheduled, asked for study information, not interested, ineligible by stated criteria with no determination made, referred to study team, do not contact, wrong number. The summary and its export belong to the study record; treat retention per the protocol and sponsor requirements, not per convenience.

Counsel review notice

This guide describes rules, not legal advice, and this is a counsel-review-first category: the IRB approves the recruitment methods, the script and the contact channel; privacy counsel reviews the data path, the business associate agreement for any vendor storing protected health information, and the recording practice; the sponsor’s requirements run on top. Complete those reviews before the first block.

Compliance in one paragraph

Recruitment is part of the research activity: the IRB approves the methods, script and contact handling, and 45 CFR 46.116 governs the informed consent that follows. Use and disclosure of protected health information run under 45 CFR 164.502, with authorization or an IRB-approved waiver under 45 CFR 164.508 or 164.512(i), and a business associate agreement is expected for vendors storing or processing protected health information. On the calling side, TCPA wireless restrictions apply under 47 CFR 64.1200(a)(1), solicitation hours run 8 a.m. to 9 p.m. local under 64.1200(c)(1), and several states require all-party consent to record. DialBreeze places calls and takes notes; it does not obtain consent, determine eligibility, or manage the protocol record. This is a description of rules, not compliance advice.