High-regulation notice
This is a C fit. Trial recruitment is research activity, not sales activity, and the rules follow from that. The IRB must approve the recruitment method, the advertisement and the script. Where protected health information is involved, the HIPAA Privacy Rule governs how contact information is used, and a business associate agreement is expected for a vendor that stores or processes that information. Nothing here is legal advice.
Get IRB approval and a privacy review before the first dial block, and confirm what the protocol and the sponsor allow the calling record to contain.
What this page actually covers
DialBreeze places live calls with a person on every answered line, up to three lines at once, and can record and summarize calls when that is enabled. In a research setting each of those features is a protocol decision: what the caller says, whether the call is recorded, what the notes contain, and how long they exist.
The defensible uses are narrow. Prescreening calls to people who consented to contact or responded to an approved advertisement, scheduling calls for screening visits, follow-up with people who started screening, and referrer coordination.
Three workflows, within the protocol
Prescreening interest calls. The caller confirms interest, reads the study description as approved, and books a screening visit. It collects what the script collects and nothing more.
Screening follow-up. People who started and did not return get called under the study’s contact schedule, which the IRB approved, with a defined number of attempts.
Referrer coordination. Community clinics and physicians are called about study availability so they know where to send interested patients.
What the note should contain, and what it should not
Contact preferences, appointment times, the questions asked and the referral route. It should not contain an eligibility determination, a diagnosis, or clinical data that belongs in the protocol record. Access should be limited to the recruitment team and the research staff the protocol names, and retention should follow the study’s own document control requirements rather than a tool default.
The rules that stack
Under 45 CFR 46.116 an investigator must obtain legally effective informed consent before involving a human subject in covered research, and consent must be sought under circumstances that give the prospective subject enough opportunity to consider participation and that minimize coercion or undue influence. That is why a recruitment call cannot double as a consent conversation.
Where a covered entity or its business associate holds protected health information, 45 CFR 164.502(a) permits use for research only as that subpart allows, typically through an authorization under 45 CFR 164.508 or a waiver or alteration approved under 45 CFR 164.512(i). On the calling side, 47 CFR 64.1200(a)(1) restricts autodialed and prerecorded calls to wireless numbers, calling hours run 8 a.m. to 9 p.m. local time at the called party’s location, and several states require all-party consent before recording. Sponsors add their own requirements on top.
Why publish this page at all
Research sites search for a recruitment dialer, and the honest answer is that the approval process is the hard part. A page that ignored the IRB and privacy sequence would put a study at risk. This page states the sequence: approval, agreement, script, then calls.
What you need to start
- Written IRB approval for the recruitment plan and materials.
- A completed HIPAA analysis and a business associate agreement where it applies.
- Your own Telnyx account with numbers and caller ID the site controls.
- A contact and retention schedule that matches the protocol.
The 14-day trial runs in a sandbox with test numbers and should not hold real participant data until approvals are in place.
Screening appointment show rates
In trial recruitment the metric that matters is not how many people expressed interest. It is how many actually attended the screening visit, because every no-show costs a coordinator hour and delays a milestone.
The calls that improve show rates are specific and administrative: confirm the time, confirm the location, confirm what to bring, and confirm that the person still wants to participate. Where a coordinator can also flag a conflict and reschedule before the visit, the site recovers the appointment instead of losing it.
Keep confirmation calls on their own dispositions so the study team can see attendance separately from interest. Reported interest that never converts is a data point about the recruitment channel, and it is worth knowing.
Why eligibility stays off the phone
A recruitment call is not a screening determination and should never be treated as one. The caller reads what the approved script contains and records interest, questions and scheduling. Any judgment about whether someone qualifies belongs to the research team and the protocol.
That division protects the study. A coordinator who says “you sound eligible” on a call creates an expectation the protocol may not support, and a participant who is later found ineligible has a legitimate grievance. The safer phrasing is the accurate one: the screening visit is where eligibility is determined, and a clinician makes that determination.
What a research site gains from the note
A well-kept contact note tells the study team three things at a glance: how the person heard about the study, what question they asked, and whether they asked not to be contacted again. That is enough to route the follow-up correctly.
It also gives the site something the protocol usually requires: a documented record of recruitment contacts. Sites are frequently asked to demonstrate that recruitment happened as approved, with the approved materials and within the approved contact schedule. A calling workflow that records dates and outcomes helps produce that record, as long as the information kept there stays inside what the protocol and IRB allow.