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AI agent for clinical research coordinators

Consent Form Version Check Agent

Every participant has a complete consent form of the correct version, and every mismatch has an approved reconsent plan.

ComplianceQuality controlScience and researchOperationsHealthcare
See how it worksGet access
Consent Form Version Check Agent: what goes in, what the agent does and what you get

What it does

After a protocol amendment, the new consent form is approved on one date and used from another, and a participant may still sign the old one. This agent compares each signed consent form to the version that was approved and in effect on the day of signing. It checks version number, date, page count and signatures, and flags mismatches or missing pages. For each mismatch it classifies the problem, drafts a reconsent plan with timing, and lists who must be informed. It rechecks when reconsent forms are filed. The coordinator and investigator approve the plan. Edge case: a form signed during the gap between IRB approval and the site's go-live date is flagged for review, not auto-failed.

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, continueApprovedYes, continueNoNo 1 STARTS WHEN Consent form filed or amendment approved 2 USES A TOOL Read the version history with approval and effectivedates 3 USES A TOOL Read each signed form's version, date, pages andsignatures 4 DOES Match each form to the version in effect on itssigning date 5 CHECKS THE RESULT Are version, pages and signatures correct for everyform? If not: classify the problem and list the affectedparticipants. Back to step 3. 6 DOES Draft a reconsent plan with timing for each affectedparticipant 7 YOU APPROVE Coordinator and investigator approve the plan 8 USES A TOOL Read newly filed reconsent forms 9 CHECKS THE RESULT Does each reconsent form meet the version, page andsignature rules? If not: return the form for correction and keep theparticipant on the open list. Back to step 8. 10 DOES Update the log and prepare a note to file 11 RESULT Consent compliance log
Read the steps as a list
  1. Consent form filed or amendment approved
  2. Read the version history with approval and effective dates
  3. Read each signed form's version, date, pages and signatures
  4. Match each form to the version in effect on its signing date
  5. Are version, pages and signatures correct for every form?If not: classify the problem and list the affected participants. Back to step 3.
  6. Draft a reconsent plan with timing for each affected participant
  7. Coordinator and investigator approve the planThe agent waits here for your OK.
  8. Read newly filed reconsent forms
  9. Does each reconsent form meet the version, page and signature rules?If not: return the form for correction and keep the participant on the open list. Back to step 8.
  10. Update the log and prepare a note to file
  11. Consent compliance log

How it decides

The correct version is the one in effect on the date of signing. A mismatch, a missing page or a missing signature fails the check.

  • Wrong version signed after the effective date: reconsent needed and a deviation record
  • Missing page: reconsent or investigator review
  • Signed in the gap before the site go-live date: flag for investigator judgment
  • Reconsent not completed by the next visit: escalate before any procedure

Make it yours

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

  • Version history source
  • Fields checked on each form
  • Reconsent timing rules
  • Deviation form template
  • Check frequency

What keeps you in control

It always asks you first

  • The reconsent plan
  • Any deviation report

Hard limits

  • Never alter or fill in a signed form
  • Never advise a participant directly

It stops when

  • Done: all participants have the correct forms
  • Stop: participant withdraws

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 happensAfter amendment 3 took effect on 1 June, the agent checked 24 forms. Participant 017 signed on 5 June using version 2.0 instead of 3.0. The check failed. It drafted a reconsent plan for the 19 June visit and a deviation note. The investigator approved. On 19 June the reconsent was filed with all pages and signatures, and the agent closed the item.

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