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Research · · 4 min read

How to pre-screen clinical trial volunteers by phone

A practical guide for research sites: what a phone pre-screen should and shouldn't do, how to order questions, what to say first, and how to handle every outcome.

A volunteer who sees your ad and picks up the phone is as interested as they'll ever be. If the call goes to voicemail and someone returns it three days later, a good share of them will have lost interest, forgotten which study it was, or found another site.

A short phone pre-screen catches people at that moment and sorts out who is worth booking for a screening visit. Done well, it saves your coordinators hours. Done badly, it annoys volunteers and fills your schedule with screen fails.

Pre-screening is not screening

Keep the two separate in your head and in your script.

A phone pre-screen asks a handful of simple questions to decide whether a screening visit makes sense. It doesn't decide eligibility, and it shouldn't sound like it does.

Screening happens at the site, after informed consent, under the protocol, with qualified staff. That's where eligibility is decided.

The pre-screen's job is to avoid booking a visit for someone who clearly can't take part, and to make the visit easy to book for someone who might.

Get the script approved before you use it

Recruitment materials, including phone scripts, usually need IRB review before you use them. Submit the actual questions and the actual words the caller will hear, not a summary.

Ask your IRB and privacy officer two questions up front:

  • Do we need a HIPAA authorization, or an approved waiver, to collect and keep pre-screening answers?
  • How long may we keep the answers from people who don't go on to screen, and may we contact them about future studies?

Write the answers down. You'll need them for the "not a fit" calls later.

Put the quick disqualifiers first

Order questions so that the ones most likely to rule someone out come first. Nobody wants to answer twelve questions to learn that the study is for people under 65.

A typical order:

  1. 1.Age range
  2. 2.The condition the study is about, in plain words
  3. 3.Whether they can travel to the site for the visits
  4. 4.Availability for the visit schedule
  5. 5.A small number of exclusions a volunteer can answer themselves

Leave anything that needs medical judgment, lab values or a records review for the screening visit.

Write questions a volunteer can actually answer

Turn protocol language into the words people use.

  • "Do you have a history of myocardial infarction?" becomes "Have you ever had a heart attack?"
  • "Are you currently taking anticoagulants?" becomes "Do you take a blood thinner, like warfarin or Eliquis?"
  • "BMI between 18 and 35" becomes two questions, height and weight, that your team converts.

Ask one thing per question. "Do you smoke or drink?" gets you an answer you can't use.

Open the call properly

The first thirty seconds set the tone. Say who you are, which study, that it's voluntary, how long it takes, and what happens to the answers. For example:

Thanks for calling the study line at Lakeside Clinical Research. This is about the migraine study you saw. I'll ask a few quick questions to see whether a screening visit could make sense. It takes about three minutes, it's completely voluntary, and you can stop at any time. Is now a good time?

If the caller hesitates, offer to call back at a time that suits them, and do it.

Know what to do with every outcome

Likely fit: book the screening visit while they're on the phone. Offer two specific times rather than asking "when works for you?". Confirm by text with the address and what to bring.

Not a fit: thank them, say plainly that this study isn't the right one, and ask whether they'd like to hear about future studies. Only keep their details if they say yes and your approvals allow it.

Not sure: don't guess. Tell them a coordinator will call back, and flag the call with the exact answer that needs a closer look.

Asks to stop: record it immediately and make sure nobody calls that number again, from any study.

Capture answers so the coordinator doesn't re-ask

Nothing undermines a volunteer's confidence like being asked the same questions twice. Record, for each call:

  • name and callback number, read back to confirm
  • which study, and how they heard about it
  • each pre-screen answer, in their words where it matters
  • the outcome and anything promised
  • consent to contact about future studies, if given

Call back web leads quickly

Volunteers who fill in a web form often do it in the evening. A callback the next morning is much more likely to reach them than one the following week.

  • Call back as soon as you can, during reasonable hours in their time zone.
  • If there's no answer, try again later in the day rather than three times in an hour.
  • Send a short text when calls don't connect, if you have permission to text.
  • Stop after a set number of attempts, and log each one.

Mistakes that cost you volunteers

  • Asking more questions than the decision needs
  • Using protocol language on the phone
  • Hinting that someone is eligible, or quoting payment before they've screened
  • Losing opt-outs between studies or between staff
  • Mixing up studies when one phone line serves several of them

Where Telani fits

Telani answers your study line and calls back web leads: it works your approved inclusion and exclusion criteria into the call one at a time, never tells callers whether they qualify, books a screening visit for callers who want to go ahead, and gives your coordinator an AI pre-screen result to review. When someone on a follow-up call asks not to be called, the number goes on your do-not-call list once the call is reviewed, and no study calls it again. One number can serve several studies.

Start with your next call. Pick your type, sign up, get a number.