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AI agent for clinical research coordinators

Research Participant Screening and Safety Agent

Only eligible participants with complete consent are enrolled, and risks are escalated promptly

Research Participant Screening and Safety Agent: what goes in, what the agent does and what you get

What it does

Enrolling a participant who should have been excluded can harm them and spoil the data. This agent applies the study's screening criteria to each response set. It flags exclusion criteria and risk items, such as suicidal ideation or an unsafe condition, and sends high-risk responses to the researcher immediately. It schedules follow-up checks when something is unclear and verifies that informed consent is complete before any data collection. After answers come in, it rechecks the screening. The researcher approves enrollment. Edge case: a participant meets all criteria but a medication answer is unclear, so the agent holds enrollment until it is clarified.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueYes, continueApprovedNoNo 1 STARTS WHEN Screening response received 2 USES A TOOL Read the responses and the study criteria 3 DOES Check each inclusion and exclusion criterion 4 CHECKS THE RESULT Is any risk item present in the responses? If not: alert the researcher at once and pausescreening. Back to step 3. 5 DOES List unclear or missing answers 6 USES A TOOL Schedule a follow-up check for unclear items 7 USES A TOOL Read the follow-up answers 8 CHECKS THE RESULT Are all criteria resolved and consent complete? If not: keep the participant on hold and request what ismissing. Back to step 4. 9 YOU APPROVE Researcher approves enrollment 10 DOES Update the enrollment log 11 RESULT Enrollment decision record
Read the steps as a list
  1. Screening response received
  2. Read the responses and the study criteria
  3. Check each inclusion and exclusion criterion
  4. Is any risk item present in the responses?If not: alert the researcher at once and pause screening. Back to step 3.
  5. List unclear or missing answers
  6. Schedule a follow-up check for unclear items
  7. Read the follow-up answers
  8. Are all criteria resolved and consent complete?If not: keep the participant on hold and request what is missing. Back to step 4.
  9. Researcher approves enrollmentThe agent waits here for your OK.
  10. Update the enrollment log
  11. Enrollment decision record

How it decides

Any exclusion or unresolved item holds enrollment. Risk items are escalated at once.

  • Escalate any risk item immediately
  • Hold enrollment while any criterion is unclear
  • Require signed consent before the first measure
  • Never override an exclusion

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Screening criteria
  • Risk items and escalation contacts
  • Follow-up timing
  • Consent requirements

What keeps you in control

It always asks you first

  • Enrollment
  • Any contact with a participant at risk

Hard limits

  • Never enrolls a participant
  • Never gives advice to a participant at risk

It stops when

  • Done: participant enrolled or excluded with reason
  • Stop: risk item requires clinical follow-up

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensParticipant 58 met age and diagnosis criteria but answered a medication item with a dose that did not match the exclusion list. The check for resolved criteria failed. The agent held enrollment and scheduled a follow-up call. The answer showed a dose under the limit. Consent was signed on May 6. The researcher approved enrollment and the agent logged the decision.

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